Document 20617
Ministry of Health Pharmaceutical Administration Drug Registration Department ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʣʲʮʤʴʥʷʺʡʥʮʹʸʰʹʭʩʸʩʹʫʺ ʭʩʹʣʧʭʩʸʩʹʫʺʥʮʹʸʰʫ ʤʱ ʯʸʶʩ B.BRAUN MEDICAL S.A., SPAIN ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ BIOAVENIR LTD I.V ʸʩʹʫʺʭʹ FLUCONAZOL ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 09/06/2009 140-93-31445-00 &U\SWRFRFFRVLV 6\VWHPLFFDQGLGLDVLVPXFRVDOFDQGLGLDVLV FLUCONAZOLE 2 MG/ML ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE GLASS TYPE I 50 ML; BOTTLE GLASS TYPE I 100 ML; BOTTLE GLASS TYPE I 200 ML HAUPT PHARMA MUNSTER GmbH, GERMANY ABIC MARKETING LTD PER OS SHELLY 09/06/2009 Oral contraception. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ETHINYLESTRADIOL 0.03 MG ; GESTODENE 0.075 MG BLISTER 1 x 21 TABLETS; BLISTER 3 x 21 TABLETS HAUPT PHARMA MUNSTER GmbH, GERMANY ABIC MARKETING LTD PER OS EMILY 09/06/2009 Oral contraception. BLISTER 1 x 21 TABLETS; BLISTER 3 x 21 TABLETS TEVA PHARMACEUTICAL INDUST.LTD OCULAR DORZOLAMIDE TIMOLOL TEVA 09/06/2009 For the treatment of elevated intracular pressure (IOP) in patients with ocular hypertension, open-angle glaucoma, or other secondary open-angle glaucoma, when concomitant therapy is appropriate. DORZOLAMIDE AS HYDROCHLORIDE 2% ; TIMOLOL AS MALEATE 0.5% BOTTLE LDPE 5 ML PHARMASCIENCE INC., CANADA RAFA LABORATORIES LTD 140-87-31769-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ GESTODENE 0.075 MG ; ETHINYLESTRADIOL 0.02 MG TEVA PHARMACEUTICAL INDUSTRIES LTD 140-88-31770-00 PER OS RAMIRIL PLUS 5 MG/25 MG Essential hypertension. Ramiril Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone. RAMIPRIL 5 MG ; HYDROCHLOROTHIAZIDE 25 MG BLISTER 30 ʪʥʺʮʣʥʮʲ 09/06/2009 140-91-31699-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 140-89-31826-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ PHARMASCIENCE INC., CANADA ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ RAFA LABORATORIES LTD PER OS ʸʩʹʫʺʭʹ RAMIRIL PLUS 2.5 MG/12.5 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 09/06/2009 140-90-31827-00 Essential hypertension. Ramiril Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ RAMIPRIL 2.5 MG ; HYDROCHLOROTHIAZIDE 12.5 MG BLISTER 30 STIEFEL LABORATORIES (IRELAND) LTD PERRIGO ISRAEL AGENCIES LTD TOPICAL DUAC ® 09/06/2009 Mild to moderate acne vulgaris, particulary inflammatory lesions. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ CLINDAMYCIN PHOSPHATE 1.28 %W/W ; BENZOYL PEROXIDE HYDROUS 6.67 %W/W TUBE 25 G SAM-ON LTD., BAT-YAM SAM-ON LTD PER OS KALBETEN FORTE CAPLETS 18/06/2009 Relief of diarrhea, nausea, flatulence, convulsive stomach pains, uspet stomach. As a preventative treatment of traveler's diarrhea. BLISTER 10 ; BLISTER 20 TARO PHARMACEUTICAL INDUSTRIES LTD TARO PHARMACEUTICAL INDUSTRIES PER OS LTD Treatment of primary generalised tonic - clonic seizures and partial seizures with or without secondary generalization. TREXAPIN 150 18/06/2009 BLISTER 50 TABLETS PER OS KALETRA 100 MG/25 MG TABLETS 01/07/2009 Kaletra is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infections. BOTTLE HDPE 60 TABLETS DEXCEL LTD 141-07-32003-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ LOPINAVIR 100 MG ; RITONAVIR 25 MG DEXCEL LTD 140-96-31747-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ OXCARBAZEPINE 150 MG ABBOTT LABORATORIES S.A. 140-95-31841-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BISMUTH SUB SALICYLATE 524 MG ABBOTT LABORATORIES LTD., ENGLAND 140-92-31439-00 PER OS VASODIP COMBO 10 Treatment of essential hypertension in whose blood pressure cannot be adequately controlled under Lercanidipine monotherapy. 01/07/2009 141-06-31726-00 ʤʩʥʥʺʤ LERCANIDIPINE HYDROCHLORIDE 10 MG ; ENALAPRIL MALEATE 10 MG ʭʩʡʩʫʸʮ BLISTER PA/ALUMINIUM/PVC 10 ; BLISTER PA/ALUMINIUM/PVC 14 ; BLISTER PA/ALUMINIUM/PVC 15 ; BLISTER PA/ALUMINIUM/PVC 20 ; BLISTER PA/ALUMINIUM/PVC ʺʥʦʩʸʠ 28 ; BLISTER PA/ALUMINIUM/PVC 30 ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ DEXCEL LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ DEXCEL LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ VASODIP COMBO 20 ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 01/07/2009 141-05-31727-00 Treatment of essential hypertension in patients whose blood pressure cannot be adequately controlled under Enalapril monotherapy. ʤʩʥʥʺʤ LERCANIDIPINE HYDROCHLORIDE 10 MG ; ENALAPRIL MALEATE 20 MG ʭʩʡʩʫʸʮ BLISTER PA/ALUMINIUM/PVC 10; BLISTER PA/ALUMINIUM/PVC 14; BLISTER PA/ALUMINIUM/PVC 15; BLISTER PA/ALUMINIUM/PVC 20; BLISTER PA/ALUMINIUM/PVC 28; ʺʥʦʩʸʠ BLISTER PA/ALUMINIUM/PVC 30 MERCK SHARP & DOHME (ITALIA) S.P.A. MERCK SHARP & DOHME ISRAEL LTD PER OS FOSAVANCE 70/5600 TABLETS 01/07/2009 140-99-31792-00 Fosavance is indicated for : Treatment of Osteoporosis in postmenopausal women: for the treatment of osteoporosis, Fosavance increases bone mass and reduces the incidence of ʤʩʥʥʺʤ fractures, including those of the hip and spine (vertebral compression fractures). Treatment to increase bone mass in men with osteoporosis. CHOLECALCIFEROL 140 MCG ; ALENDRONIC ACID ANHYDROUS AS ALENDRONATE SODIUM TRIHYDRATE 70 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 2 TABLETS; BLISTER 4 TABLETS SANOFI PASTEUR S.A., FRANCE MEDICI LTD I.M VERORAB 01/07/2009 Prevention of rabies in children and adults. It can be used before and after exposure, as a primary vaccination or as a booster dose. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ RABIES, INACTIVATED, WHOLE VIRUS 2.5 IU VIAL GLASS TYPE I 3 ML; VIAL GLASS TYPE I 3 ML SANOFI PASTEUR LTD, CANADA MEDICI LTD PEDIACEL 140-97-31875-00 01/07/2009 141-01-31746-00 Pediacel is indicated for immunization of children at or above the age of 2 months and as a booster in children up to their 7th birthday against diphtheria, tetanus, whooping cough, ʤʩʥʥʺʤ poliomyelitis and invasive Haemophilus influenzae type b disease. In infants, three infectons are to be given intramuscularly at 2, 4 and 6 months of age followed by a booster at 18 months of age. Children who have had pertusis, tetanus, diphtheria or haemophilus influenzae type b invasive disease should still be immunized since these clinical infections do not always confer immunity. Children who have had natural pertussis can continue to receive pertussis - containing vaccines. Human immunodeficiency virus (HIV) infected persons HIV - infected individuals, both asymptomatic and symptomatic, should be immunized with Pediacel vaccine according to standard schedules. PERTACTIN (PRN) 3 MCG ML ; DIPHTHERIA TOXOID 15LF ML ; TETANUS TOXOID 5LF ML ; PERTUSSIS TOXOID VACCINE 20 MCG ML ; FILAMENTOUS ʭʩʡʩʫʸʮ HAEMOGGLUTININ (FHA) 20 MCG ML ; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG ML ; POLIOVIRUS TYPE 1 40DU ML ; POLIOVIRUS TYPE 2 8DU ML ; POLIOVIRUS TYPE 3 32DU ML ; PRP OF HAEMOPHILUS INFL. TYPE B 10 MCG ML VIAL 1 x 0.5 ML; VIAL 5 x 0.5 ML ʺʥʦʩʸʠ FLORIS LTD FLORIS LTD DERMAL For the disinfection of skin infections and inflammations, wounds and superficial burns. IODIFLOR OINTMENT 01/07/2009 141-02-31802-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ POVIDONE-IODINE 10% BOTTLE HDPE 250 G; TUBE LDPE 15 G; TUBE LFPE 50 G ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ FLORIS LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ FLORIS LTD ʯʥʰʩʮʺʸʥʶ DERMAL ʸʩʹʫʺʭʹ POLYSKIN OINTMENT (LIFE) ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 01/07/2009 141-03-31804-00 For the disinfection of skin infections and inflammations, wounds and superficial burns. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ POVIDONE-IODINE 10% TUBE LDPE 15 G; TUBE LFPE 50 G KELA N.V. BELGIUM M.P.VET LTD PER OS IN DRINKING AMOXYKEL 70 SOLUBLE WATER POWDER VETERINARY Amoxykel 70 is indicated for the treatment of infections caused by microorganisms sensitive to Amoxicillin in broilers and pigs. 01/07/2009 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ AMOXICILLIN AS TRIHYDRATE 1G/DOSE BAG ALUMINIUM 100 G; BAG ALUMINIUM 1000 G PERRIGO COMPANY, USA PERRIGO ISRAEL AGENCIES LTD TOPICAL FLEXIDERM 01/07/2009 Temporarily relieves the minor aches and pains of muscles and joints associated with simple bacaches, arthritis, strains, bruises and sprains. TUBE 113 G LUXEMBURG PHARMACEUTICALS LTD I.V FERROVIN 140-98-31745-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ CAMPHOR 4% ; MENTHOL 10% ; METHYL SALICYLATE 30% RAFARM S.A., GREECE 140-94-92422-00 01/07/2009 141-09-31806-00 Severe iron deficiency only when oral administration has been found impossible. In cases of gastro- intestinal malobsorption which rules our oral therapy, patients on dialysis treated ʤʩʥʥʺʤ with erythropoietin. ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ IRON SUCROSE 20MG/ML AMPOULES GLASS TYPE I 5 ABBOTT LABORATORIES LTD., ENGLAND ABBOTT LABORATORIES S.A. PER OS ZEMPLAR 1 MICROGRAM 19/07/2009 141-12-31816-00 Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients ʤʩʥʥʺʤ and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis. PARICALCITOL 1 MCG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 7 CAPSULES; BLISTER 28 CAPSULES ABBOTT LABORATORIES LTD., ENGLAND ABBOTT LABORATORIES S.A. PER OS ZEMPLAR 2 MICROGRAM 19/07/2009 141-13-31817-00 Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients ʤʩʥʥʺʤ and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis. PARICALCITOL 2 MCG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 7 CAPSULES; BLISTER 28 CAPSULES ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ABBOTT LABORATORIES LTD., ENGLAND ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ABBOTT LABORATORIES S.A. ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ ZEMPLAR 4 MICROGRAM ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 19/07/2009 141-14-31818-00 Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal insufficiency (chronic kidney disease stage 3 and 4 ) patients ʤʩʥʥʺʤ and chronic renal failure (chronic kidney disease stage 5) patients on haemodialysis or peritoneal dialysis. PARICALCITOL 4 MCG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 7 CAPSULES; BLISTER 28 CAPSULES TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS RISPOND SOLUTION 20/07/2009 141-17-31711-00 Rispond is indicated for the management of schizophrania and manifestation of psychotic disorders. The antipsychotic efficacy of Rispond was established in short-term (6 to 8 ʤʩʥʥʺʤ weeks) controlled trials of schizophrenic inpatients. Rispond is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Rispond is indicated for the treatment of psychotic manifestations of dementia. Conduct and other disruptive disorders: Treatment of behavioral disorders expressed by impulse control disorders or self-alienated-aggressive or treatment- requiring behavioral disorders with reduced or substandard intelligence. Treatment should not be given to children under the age of 5 years. Rispond is indicated for the treatment of mania in bipolar disorder. These episodes are characterized by symptoms such as elevated expansive or irritable mood inflated self-esteem decreased need for sleep pressured speech racing thoughts distractibility or poor judgment including disruptibe or aggressive behaviors. ʭʩʡʩʫʸʮ RISPERIDONE 1MG/ML ʺʥʦʩʸʠ BOTTLE AMBER GLASS III 30 ML; BOTTLE AMBER GLASS III 100 ML RAFA LABORATORIES LTD, JERUSALEM RAFA LABORATORIES LTD PER OS RAMITENS PLUS 2.5 MG/12.5 MG 20/07/2009 Essential hypertension. Ramitens Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ RAMIPRIL 2.5 MG ; HYDROCHLOROTHIAZIDE 12.5 MG BLISTER 30 TABLETS RAFA LABORATORIES LTD, JERUSALEM RAFA LABORATORIES LTD PER OS RAMITENS PLUS 5 MG/25 MG 20/07/2009 Essential hypertension. Ramitens Plus is indicated in patients whose blood pressure cannot be adequately lowered with ramipril alone. BLISTER 30 TABLETS TEVA PHARMACEUTICAL INDUST.LTD PER OS METFORMIN TEVA ® 141-16-31689-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ RAMIPRIL 5 MG ; HYDROCHLOROTHIAZIDE 25 MG TEVA PHARMACEUTICAL INDUSTRIES LTD 141-15-31688-00 31/07/2009 Metformin Teva is indicated in diet - failed non - insulin dependent diabetic patients especially if overweight either alone as initial therapy or in combination with a sulfonylurea. Occasionally as adjuvant therapy in insulin - dependent diabetic patients particularly who are usually obese and not well controlled with insulin. 130-25-30822-13 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ METFORMIN HYDROCHLORIDE 850 MG BLISTER PVDC/ALUMINIUM 30 ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ JANSSEN PHARMACEUTICA N.V.,BELGIUM ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ABIC VETERINARY PRODUCTS LTD PER OS ʸʩʹʫʺʭʹ YARVITAN VETERINARY ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 31/07/2009 141-08-92425-00 As an aid in management of overweight and obesity in dogs. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ MITRATAPIDE 5MG/ML BOTTLE AMBER GLASS 55 ML; BOTTLE AMBER GLASS 120 ML; BOTTLE AMBER GLASS 210 ML SCHERING GmbH & Co.PRODUKTIONS KG BAYER ISRAEL LTD PER OS YAZ 31/07/2009 141-04-32023-00 2UDOFRQWUDFHSWLRQ ʤʩʥʥʺʤ 7UHDWPHQWRIPRGHUDWHDFQHYXOJDULVLQZRPHQZKRVHHNRUDOFRQWUDFHSWLRQ 7UHDWPHQWRIV\PSWRPVRISUHPHQVWUXDOG\VSKRULFGLVRUGHU30''LQZRPHQZKRKDYHFKRVHQRUDOFRQWUDFHSWLYHVDVWKHLUPHWKRGRIELUWKFRQWURO7KHHIILFDF\RI<D]IRU30'' ZDVQRWDVVHVVHGEH\RQGF\FOHV<D]KDVQRWEHHQHYDOXDWHGIRUWUHDWPHQWRI306SUHPHQVWUXDOV\QGURPH DROSPIRENONE 3 MG ; ETHINYLESTRADIOL 0.02 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 6 x 28 TABLETS; BLISTER 1 x 28 TABLETS; BLISTER 3 x 28 TABLETS RIVOPHARM SA, SWITZERLAND PERRIGO ISRAEL AGENCIES LTD PER OS ALFU-KAL XL 01/08/2009 Treatment of certain functional symptoms of benign prostatic hypertrophy, particularly if surgery has to be delayed for some reason. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ALFUZOSIN HYDROCHLORIDE 10 MG BLISTER 30 TABLETS CTS CHEMICAL INDUSTRIES LTD CTS CHEMICAL INDUSTRIES LTD PER OS LOSARTAN PLUS 141-23-31829-00 01/08/2009 141-24-31703-00 For the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ HYDROCHLOROTHIAZIDE 12.5 MG ; LOSARTAN AS POTASSIUM 50 MG BLISTER 7 TABLETS; BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS; BLISTER 100 TABLETS MAX ZELLER SOHNE, SWITZERLAND RAFA LABORATORIES LTD PER OS REMOTIV 500 01/08/2009 Symptoms of mild to moderate depression including: dejected mood, mood lability, inner restlessness, anxiety, states of tension and the difficulty in falling asleep and sleeping through the night which is associated with these conditions. HYPERICI HERBA EXTRACTUM SICCUM 500 MG BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 60 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 120 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 10 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS DONEPEZIL TEVA ® 10 MG Treatment of mild to moderately severe Alzheimer's dementia. 01/08/2009 141-28-31607-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-26-31461-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ DONEPEZIL HYDROCHLORIDE 10 MG BLISTER 30 TABLETS ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ TEVA PHARMACEUTICAL INDUST.LTD PER OS ʸʩʹʫʺʭʹ DONEPEZIL TEVA ® 5 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 01/08/2009 141-25-31460-00 Treatment of mild to moderately severe Alzheimer's dementia. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ DONEPEZIL HYDROCHLORIDE 5 MG BLISTER 30 TABLETS ULTRADENT PRODUCTS INC, USA R.N . DENTO MEDICAL DIVISION LTD LOCAL ORAL ULTRACARE (BUBBLE GUM 01/08/2009 141-27-31937-00 FLAVOR) For any dental procedure in which topical anesthesia is desired. For temporary relief of pain associated with : canker sores dental procedures minor injury of the mouth and gum ʤʩʥʥʺʤ caused by dentures or orthodentic appliances. BENZOCAINE 20 %W/V ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE PLASTIC 30 ML; SYRINGE POLYPROPYLENE 30 ML; SYRINGE POLYPROPYLENE 1.2 ML UNIGENE LABORATORIES INC., USA TZAMAL BIO-PHARMA LTD NASAL FORTICAL 10/08/2009 )RUWLFDO1DVDO6SUD\LVLQGLFDWHGIRU 3RVWPHQRSDXVDO2VWHRSRURVLV±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ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL AMBER GLASS TYPE I 3.7 ML JANSSEN CILAG S.P.A., ITALY J-C HEALTH CARE LTD 141-31-31800-00 PER OS INTELENCE 10/08/2009 141-29-31789-00 Intelence is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment ʤʩʥʥʺʤ -experienced adult patients including those with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. Treatment history and when available resistance testing should guide the use of Intelence. In patients who have experienced virological failure on an NNRTI- and nucleoside or nucleotide reverse transcriptase inhibitor (N[t]RTI)- containing regimen Intelence is not recommended for use in combination with N(t)RTIs only. ETRAVIRINE 100 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE 120 TABLETS TRIMA ISRAEL PHARM.PROD.MAABAROT LTD TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD Parkinson's disease. Combination therapy with L-dopa and as monotherapy for newly diagnosed illness. PER OS CABERGOLINE 2 MG BOTTLE POLYETHYLENE 30 TABLETS ʪʥʺʮʣʥʮʲ CABOTRIM 2 10/08/2009 141-30-32035-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ TEVA PHARMACEUTICAL INDUST.LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ ANASTROZOLE TEVA ® ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 10/08/2009 141-32-31760-00 Treatment of advanced breast cancer in post menopausal women. Efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive ʤʩʥʥʺʤ clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. ANASTROZOLE 1 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVDC/ALUMINIUM 30 TABLETS ALZA CORPORATION, USA J-C HEALTH CARE LTD PER OS JURNISTA 4 MG 11/08/2009 141-42-31956-00 Treatment of severe pain. ʤʩʥʥʺʤ HYDROMORPHONE HYDROCHLORIDE 4 MG ʭʩʡʩʫʸʮ BLISTER PVC/ACLAR 7 TABLETS; BLISTER PVC/ACLAR 10 TABLETS; BLISTER PVC/ACLAR 14 TABLETS; BLISTER PVC/ACLAR 20 TABLETS; BLISTER PVC/ACLAR 28 ʺʥʦʩʸʠ TABLETS; BLISTER PVC/ACLAR 30 TABLETS; BLISTER PVC/ACLAR 35 TABLETS; BLISTER PVC/ACLAR 40 TABLETS; BLISTER PVC/ACLAR 50 TABLETS; BLISTER PVC/ACLAR 56 TABLETS; BLISTER PVC/ACLAR 60 TABLETS; BLISTER PVC/ACLAR 100 TABLETS GLAXO SMITH KLINE MANUFACTURING GLAXO SMITH KLINE (ISRAEL) LTD PER OS HYCAMTIN 1 MG 11/08/2009 SPA,ITALY Indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. TOPOTECAN HYDROCHLORIDE 1 MG BLISTER PVC/PCTFE 10 CAPSULES GLAXO SMITH KLINE MANUFACTURING GLAXO SMITH KLINE (ISRAEL) LTD PER OS HYCAMTIN 0.25 MG SPA,ITALY Indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. 11/08/2009 BLISTER PVC/PCTFE 10 CAPSULES SANOFI - AVENTIS ISRAEL LTD I.V CLEXANE 11/08/2009 Treatment of acute ST-segment elevation myocardial infarction, in combination with a thrombolytic agent in patients eligible or not for subsequent coronary angioplasty. ENOXAPARIN SODIUM 100 MG/ML VIAL GLASS TYPE I 1 x 3 ML ʪʥʺʮʣʥʮʲ ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-37-31862-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ TOPOTECAN HYDROCHLORIDE 0.25 MG SANOFI AVENTIS S.A., SPAIN 141-38-31863-00 141-41-32031-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ MERCK KGaA, GERMANY ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ MERCK SERONO LTD ʯʥʰʩʮʺʸʥʶ I.V ʸʩʹʫʺʭʹ ERBITUX 5 MG/ML ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ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ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 10 ML; VIAL GLASS TYPE I 20 ML; VIAL GLASS TYPE I 50 ML; VIAL GLASS TYPE I 100 ML CSL BEHRING GmbH, GERMANY MEDILINE LTD. I.V HAEMOCOMPLETTAN P 2 G 11/08/2009 +DHPRFRPSOHWWDQ3JJ)LEULQRJHQ&RQFHQWUDWH+XPDQLVLQGLFDWHGIRUWKHWUHDWPHQWRIDFXWHEOHHGLQJHSLVRGHVLQSDWLHQWVZLWKFRQJHQLWDOILEULQRJHQGHILFLHQF\LQFOXGLQJ DILEULQRJHQHPLDDQGK\SRILEULQRJHQHPLD +DHPRFRPSOHWWDQ3JJLVQRWLQGLFDWHGIRUG\VILEULQRJHQHPLD HUMAN FIBRINOGEN 1800 MG / 1 VIALS VIAL GLASS TYPE II 2 G KELA N.V. BELGIUM M.P.VET LTD PER OS IN DRINKING WATER Tylosin 75 is indicated for the treatment of infections caused by microorganisms sensitive to Tylosin in pigs. TYLOSIN -75 SOLUBLE POWDER VETERINARY 11/08/2009 BAG ALUMINIUM 133 G; BAG ALUMINIUM 1333 G MEDILINE LTD. I.V HAEMOCOMPLETTAN P 1 G 11/08/2009 +DHPRFRPSOHWWDQ3JJ)LEULQRJHQ&RQFHQWUDWH+XPDQLVLQGLFDWHGIRUWKHWUHDWPHQWRIDFXWHEOHHGLQJHSLVRGHVLQSDWLHQWVZLWKFRQJHQLWDOILEULQRJHQGHILFLHQF\LQFOXGLQJ DILEULQRJHQHPLDDQGK\SRILEULQRJHQHPLD +DHPRFRPSOHWWDQ3JJLVQRWLQGLFDWHGIRUG\VILEULQRJHQHPLD HUMAN FIBRINOGEN 900 MG / 1 VIALS VIAL GLASS TYPE II 1 G KOFFOLK (1949) LTD KOFFOLK (1949) LTD PER OS AMPROSOL VETERINARY 11/08/2009 Treatment and prevention of coccidiosis in broilers and lambs. AMPROLIUM 215 G BAG METALIC POLYETHYLENE 0.5 KG; BAG METALIC POLYETHYLENE 1 KG; BAG METALIC POLYETHYLENE 2 KG; BAG METALIC POLYETHYLENE 5 KG; BAG METALIC POLYETHYLENE 15 KG; BAG METALIC POLYETHYLENE 20 KG; BAG METALIC POLYETHYLENE 25 KG ʪʥʺʮʣʥʮʲ ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-34-92421-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ TYLOSIN AS TARTRATE 750000 IU/DOSE CSL BEHRING GmbH, GERMANY 141-36-31820-00 141-35-31819-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-39-92423-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ WEST PHARMA- PROD. DE ESPEC. BIOAVENIR LTD PER OS TIASAR 50 MG 03/09/2009 141-46-31613-00 FARMACEUT.S.A. Hypertension: Losartan is indicated for the treatment of heart failure ( NYHA II and III) usually in addition to diuretics and/or digitalis if use of an ACE inhibitor is not appropriate. ʤʩʥʥʺʤ Switching patients with heart failure who are stable on an ACE inhibitor to Tiasar is not recommended. Renal protection in Type - 2 diabetic patients with proteinuria: Losartan is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine end stage renal disease ( need for dialysis or renal transplantation) or death and to reduce proteinuria. Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrphy. Losartan is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death stroke and myocardial infarction in hypertensive patients with left ventricular hypertrphy. The benefit of Tiasar on the primary deposite end point was largely driven by reduction in the risk of stroke. LOSARTAN AS POTASSIUM 50 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS WEST PHARMA- PROD. DE ESPEC. BIOAVENIR LTD PER OS TIASAR 100 MG 03/09/2009 141-47-31614-00 FARMACEUT.S.A. Hypertension: Losartan is indicated for the treatment of heart failure ( NYHA II and III) usually in addition to diuretics and/or digitalis if use of an ACE inhibitor is not appropriate. ʤʩʥʥʺʤ Switching patients with heart failure who are stable on an ACE inhibitor to Tiasar is not recommended. Renal protection in Type - 2 diabetic patients with proteinuria: Losartan is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine end stage renal disease ( need for dialysis or renal transplantation) or death and to reduce proteinuria. Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrphy. Losartan is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death stroke and myocardial infarction in hypertensive patients with left ventricular hypertrphy. The benefit of Tiasar on the primary deposite end point was largely driven by reduction in the risk of stroke. LOSARTAN AS POTASSIUM 100 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS WEST PHARMA- PROD. DE ESPEC. BIOAVENIR LTD PER OS COTIASAR 03/09/2009 141-48-31634-00 FARMACEUT.S.A. For the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ HYDROCHLOROTHIAZIDE 12.5 MG ; LOSARTAN AS POTASSIUM 50 MG BLISTER 10 TABLETS; BLISTER 30 TABLETS; BLISTER 60 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS LEVETIRACETAM TEVA ® 1000 03/09/2009 141-45-31783-00 MG /HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQDGXOWVDQGFKLOGUHQIURP\HDUVRIDJHZLWK ʤʩʥʥʺʤ HSLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRIP\RFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWK-XYHQLOH0\RFORQLF(SLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGDVPRQRWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQSDWLHQWIURP\HDUVRIDJHZLWKQHZO\GLDJQRVHG HSLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGLQWKHWUHDWPHQWRISULPDU\JQHUDOL]HGWRQLFFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWKLGLRSDWKLFJHQHUDOLVHGHSLOHSV\ LEVETIRACETAM 1000 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 30 TABLETS; BLISTER 60 TABLETS ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ TEVA PHARMACEUTICAL INDUST.LTD ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ PER OS LEVETIRACETAM TEVA ® 500 03/09/2009 141-44-31957-00 MG /HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQDGXOWVDQGFKLOGUHQIURP\HDUVRIDJHZLWK ʤʩʥʥʺʤ HSLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRIP\RFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWK-XYHQLOH0\RFORQLF(SLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGDVPRQRWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQSDWLHQWIURP\HDUVRIDJHZLWKQHZO\GLDJQRVHG HSLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGLQWKHWUHDWPHQWRISULPDU\JQHUDOL]HGWRQLFFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWKLGLRSDWKLFJHQHUDOLVHGHSLOHSV\ LEVETIRACETAM 500 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 30 TABLETS; BLISTER 60 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS LEVETIRACETAM TEVA ® 250 03/09/2009 141-43-31958-00 MG /HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQDGXOWVDQGFKLOGUHQIURP\HDUVRIDJHZLWK ʤʩʥʥʺʤ HSLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGDVDGMXQFWLYHWKHUDS\LQWKHWUHDWPHQWRIP\RFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWK-XYHQLOH0\RFORQLF(SLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGDVPRQRWKHUDS\LQWKHWUHDWPHQWRISDUWLDORQVHWVHL]XUHVZLWKRUZLWKRXWVHFRQGDU\JHQHUDOLVDWLRQLQSDWLHQWIURP\HDUVRIDJHZLWKQHZO\GLDJQRVHG HSLOHSV\ /HYHWLUDFHWDPLVLQGLFDWHGLQWKHWUHDWPHQWRISULPDU\JQHUDOL]HGWRQLFFORQLFVHL]XUHVLQDGXOWVDQGDGROHVFHQWVIURP\HDUVRIDJHZLWKLGLRSDWKLFJHQHUDOLVHGHSLOHSV\ LEVETIRACETAM 250 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 30 TABLETS; BLISTER 60 TABLETS TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS LERCAPRESS 10 14/09/2009 Hypertension. Mild to moderate essential hypertension. LERCANIDIPINE HYDROCHLORIDE 10 MG BLISTER PVC/ALUMINIUM 5 TABLETS; BLISTER PVC/ALUMINIUM 7 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS DEXCEL LTD DEXCEL PHARMA TECHNOLOGIES LTD PER OS LOSARDEX PLUS 16/09/2009 141-51-31848-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-56-31892-00 Losardex plus is indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hypertension and ʤʩʥʥʺʤ left ventricular hypertrophy. HYDROCHLOROTHIAZIDE 12.5 MG ; LOSARTAN POTASSIUM 50 MG ʭʩʡʩʫʸʮ BLISTER PVC/PE/PVDC/AL 2 TABLETS; BLISTER PVC/PE/PVDC/AL 10 TABLETS; BLISTER PVC/PE/PVDC/AL 14 TABLETS; BLISTER PVC/PE/PVDC/AL 20 TABLETS; BLISTER PVC/PE/PVDC/AL 28 TABLETS; BLISTER PVC/PE/PVDC/AL 30 TABLETS ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ RECKITT BENCKISER HEALTHCARE (UK) RECKITT BENCKISER (NEAR EAST) LTD PER OS GAVISCON FORTE PEPPERMINT 16/09/2009 LIMITED Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn, indigestion occurring due to the reflux of stomach contents for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy or accompanying reflux oesophagitis. ALGINIC ACID AS SODIUM 100 MG/ML ; POTASSIUM HYDROGENCARBONATE 20 MG/ML BOTTLE AMBER GLASS III 150 ML; BOTTLE AMBER GLASS III 250 ML; BOTTLE AMBER GLASS III 300 ML; BOTTLE AMBER GLASS III 500 ML ʸʩʹʫʺʸʴʱʮ 141-57-31835-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ RECKITT BENCKISER HEALTHCARE (UK) RECKITT BENCKISER (NEAR EAST) LTD PER OS GAVISCON PEPPERMINT 16/09/2009 141-58-31757-00 LIMITED TABLETS Treatment of symptoms of gastro-oesophageal reflux such as acid regurgatation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in ʤʩʥʥʺʤ patients with symptoms related to reflux oesophagitis. CALCIUM CARBONATE 80 MG ; SODIUM BICARBONATE 133.5 MG ; ALGINIC ACID AS SODIUM 250 MG ʭʩʡʩʫʸʮ BLISTER PVC/PE/PVDC/AL 64 TABLETS; BLISTER PVC/PE/PVDC/AL 4 TABLETS; BLISTER PVC/PE/PVDC/AL 6 TABLETS; BLISTER PVC/PE/PVDC/AL 8 TABLETS; BLISTER PVC/PE/PVDC/AL 16 TABLETS; BLISTER PVC/PE/PVDC/AL 24 TABLETS; BLISTER PVC/PE/PVDC/AL 32 TABLETS; BLISTER PVC/PE/PVDC/AL 48 TABLETS TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS ESTO 10 17/09/2009 Treatment of depression and panic disorder. Treatment of generalized anxiety disorder (GAD), treatment of social anxiety disorder (social phobia). ESCITALOPRAM AS OXALATE 10 MG BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 20 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS ESTO 20 17/09/2009 Treatment of depression and panic disorder. Treatment of generalized anxiety disorder (GAD) treatment of social anxiety disorder (social phobia). Treatment of obsessive compulsive disorder. ESCITALOPRAM AS OXALATE 20 MG BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 20 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS SMITHKLINE BEECHAM PLC, UK GLAXO SMITH KLINE (ISRAEL) LTD PER OS REQUIP MODUTAB 2 MG 17/09/2009 ʺʥʦʩʸʠ 141-60-31712-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-61-31970-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-62-31838-00 Ropinirole is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. As adjunctive treatment to L-dopa, ʤʩʥʥʺʤ ropinirole enhances the efficacy of L-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic L-dopa therapy and permits reduction in daily Ldopa dose. ROPINIROLE AS HYDROCHLORIDE 2 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 28 TABLETS; BLISTER 84 TABLETS ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ SMITHKLINE BEECHAM PLC, UK ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ GLAXO SMITH KLINE (ISRAEL) LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ REQUIP MODUTAB 4 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 17/09/2009 141-64-31839-00 Ropinirole is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. As adjunctive treatment to L-dopa, ʤʩʥʥʺʤ ropinirole enhances the efficacy of L-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic L-dopa therapy and permits reduction in daily Ldopa dose. ROPINIROLE AS HYDROCHLORIDE 4 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 28 TABLETS; BLISTER 84 TABLETS SMITHKLINE BEECHAM PLC, UK GLAXO SMITH KLINE (ISRAEL) LTD PER OS REQUIP MODUTAB 8 MG 17/09/2009 141-63-31840-00 Ropinirole is indicated for the treatment of Parkinson's disease. Ropinirole is effective as early therapy in patients requiring dopaminergic therapy. As adjunctive treatment to L-dopa, ʤʩʥʥʺʤ ropinirole enhances the efficacy of L-dopa, including control of "on-off" fluctuations and "end of dose" effects associated with chronic L-dopa therapy and permits reduction in daily Ldopa dose. ROPINIROLE AS HYDROCHLORIDE 8 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER 28 TABLETS; BLISTER 84 TABLETS B.BRAUN MELSUNGEN AG, GERMANY LUXEMBURG PHARMACEUTICALS LTD I.V PROPOFOL LIPURO 2 % 29/09/2009 141-66-31763-00 Propofol is a short-acting intravenous anesthetic agent suitable for induction and maintenance of general anesthesia in adults. Propofol may also be used for sedation of ventilated ʤʩʥʥʺʤ adult patients receiving intensive care .for surgical procedures which do not exceed one hour in duration. Propofol may also be used for conscious sedation for surgical and diagnostic procedures. PROPOFOL 20MG/ML ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE GLASS 50 ML SANOFI - AVENTIS S.P.A., ITALY SANOFI - AVENTIS ISRAEL LTD PER OS AMARYL 4 MG 01/10/2009 Non-insulin-dependent diabetes melitus ( adult-onset diabetes, type II diabetes), when diet, regular physical exercise, and weight reduction alone cannot maintain therapeutically suitable blood glucose levels. GLIMEPIRIDE 4 MG BLISTER PVC/ALUMINIUM 120 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 60 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 120 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 60 TABLETS RECKITT & BENCKISER HEALTHCARE (UK) LTD RECKITT BENCKISER (NEAR EAST) LTD PER OS GAVISCON LIQUID PEPPERMINT 01/10/2009 Gastro reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. ALGINIC ACID AS SODIUM 50MG/ML ; SODIUM BICARBONATE 26.7MG/ML ; CALCIUM CARBONATE 16MG/ML BOTTLE AMBER GLASS 600 ML; BOTTLE AMBER GLASS 150 ML; BOTTLE AMBER GLASS 200 ML; BOTTLE AMBER GLASS 300 ML ʪʥʺʮʣʥʮʲ 141-68-31917-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-67-31756-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ SANDOZ GmbH, AUSTRIA ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ MASROUJI COMPANY LTD ʯʥʰʩʮʺʸʥʶ I.V; I.M ʸʩʹʫʺʭʹ CEFAZOLIN SANDOZ 0.5 G ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 01/10/2009 141-69-31812-00 Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis. Treatment Respiratory tract: Respiratory tract infections due to ʤʩʥʥʺʤ streptococcus pneumoniae (formerly diplococcus pneumoniae) klebsiella species haemophilus influenzae staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A B - hemolytic streptococci. Cefazolin is effective in the eradication of streptococci from the nasopharynx. However data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present. Urinary tract: Infections due to escherichia coli klebsiella species proteus mirabilis and some strains of Enterobacter and enterococci. Skin and skin structure: -hemolytic beta Infections due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A streptococci and other strains of streptococci. Biliary tract: Infections due to escherichia coli various strains of streptococci proteus mirabilis klebsiella species and staphylococcus aureus. Bone and joint : Infections due to staphylococcus aureus. Genital infections (i.e. prostatitis epididymitis) due to escherichia coli proteus mirabilis klebsiella species and some strains of enterococci. Septicemia due to streptococcus pneumoniae (formerly diplococcus pneumoniae) staphylococcus aureus (penicillin-sensitive and penicillin-resistant) proteus mirabilis escherichia coli and klebsiella species. Endocarditis caused by staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin. Perioperative prophylaxis: The prophylactic administraton of cefazolin perioperatively (preoperatively intraoperatively and postoperatively) may reduce the incidence of certain postoperative infectons in patients undergoing surgical procedures (e.g. hysterectomy gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated. The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and prosthetic arthroplasty). CEFAZOLIN AS SODIUM 500MG/VIAL ʭʩʡʩʫʸʮ VIAL GLASS TYPE III 100 x 15 ML; VIAL GLASS TYPE III 1 x 15 ML; VIAL GLASS TYPE III 5 x 15 ML; VIAL GLASS TYPE III 10 x 15 ML; VIAL GLASS TYPE III 25 x 15 ML; VIAL GLASS TYPE III 50 x 15 ML SANDOZ GmbH, AUSTRIA MASROUJI COMPANY LTD I.V; I.M CEFAZOLIN SANDOZ 1 G. 01/10/2009 ʺʥʦʩʸʠ 141-70-31813-00 Treatment of serious infections caused by susceptible organisms and also perioperatively for prophylaxis. Treatment Respiratory tract: Respiratory tract infections due to ʤʩʥʥʺʤ streptococcus pneumoniae (formerly diplococcus pneumoniae) klebsiella species haemophilus influenzae staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A B - hemolytic streptococci. Cefazolin is effective in the eradication of streptococci from the nasopharynx. However data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present. Urinary tract: Infections due to escherichia coli klebsiella species proteus mirabilis and some strains of Enterobacter and enterococci. Skin and skin structure: -hemolytic beta Infections due to Staphylococcus aureus (penicillin-sensitive and penicillin-resistant) group A streptococci and other strains of streptococci. Biliary tract: Infections due to escherichia coli various strains of streptococci proteus mirabilis klebsiella species and staphylococcus aureus. Bone and joint : Infections due to staphylococcus aureus. Genital infections (i.e. prostatitis epididymitis) due to escherichia coli proteus mirabilis klebsiella species and some strains of enterococci. Septicemia due to streptococcus pneumoniae (formerly diplococcus pneumoniae) staphylococcus aureus (penicillin-sensitive and penicillin-resistant) proteus mirabilis escherichia coli and klebsiella species. Endocarditis caused by staphylococcus aureus (penicillin-sensitive and penicillin-resistant) and group A beta-hemolytic streptococci. Appropriate culture and susceptibility studies should be performed to determine the susceptibility of the causative organism to cefazolin. Perioperative prophylaxis: The prophylactic administraton of cefazolin perioperatively (preoperatively intraoperatively and postoperatively) may reduce the incidence of certain postoperative infectons in patients undergoing surgical procedures (e.g. hysterectomy gastrointestinal surgery and transurethral prostatectomy) that are classified as contaminated or potentially contaminated. The perioperative use of cefazolin may also be effective in surgical patients in whom infection at the operative site would present a serious risk (e.g. open-heart surgery and prosthetic arthroplasty). CEFAZOLIN AS SODIUM 1G/VIAL ʭʩʡʩʫʸʮ VIAL GLASS TYPE III 100 x 15 ML; VIAL GLASS TYPE III 1 x 15 ML; VIAL GLASS TYPE III 5 x 15 ML; VIAL GLASS TYPE III 10 x 15 ML; VIAL GLASS TYPE III 25 x 15 ML; VIAL GLASS TYPE III 50 x 15 ML ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʯʸʶʩ ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ORTHO - McNEIL PHARMACEUTICAL INC, USA J-C HEALTH CARE LTD I.V ʸʩʹʫʺʭʹ DORIBAX ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 01/10/2009 141-65-31870-00 'RULED[LVLQGLFDWHGIRUWKHWUHDWPHQWRIWKHIROORZLQJLQIHFWLRQVLQDGXOWV &RPSOLFDWHGLQWUDDEGRPLQDOLQIHFWLRQV &RPSOLFDWHGXULQDU\WUDFWLQIHFWLRQV &RQVLGHUDWLRQVKRXOGEHJLYHQWRRIILFLDOJXLGDQFHRQWKHDSSURSULDWHXVHRIDQWLEDFWHULDODJHQWV DORIPENEM 500 MG ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 10 VIALS PERRIGO COMPANY, USA PERRIGO ISRAEL AGENCIES LTD NAIL MYCONAIL 01/10/2009 For the treatment of fungal infections of the nails. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ CICLOPIROX 80MG/G BOTTLE GLASS TYPE III 6.6 ML MERCK & CO., INC.,USA MERCK SHARP & DOHME ISRAEL LTD PER OS TREDAPTIVE 1000 MG/ 20 MG 20/10/2009 Tredaptive is indicated for the treatment of dyslipidaemia particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL- cholesterol and triglycerides and low HDL-cholesterol ) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins) when the cholesterol lowering effect of HMG-Coa reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet and oter non-pharmacological treatments (e.g. exercise weight reduction) should be continued during therapy with Tredaptive. NICOTINIC ACID 1000 MG ; LAROPIPRANT 20 MG BLISTER ACLAR/ALUMINIUM 14 CAPSULES; BLISTER ACLAR/ALUMINIUM 28 CAPSULES; BLISTER ACLAR/ALUMINIUM 56 CAPSULES MERCK & CO., INC.,USA MERCK SHARP & DOHME ISRAEL LTD PER OS TREDAPTIVE 1000 MG/ 20 MG 20/10/2009 Tredaptive is indicated for the treatment of dyslipidaemia particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL- cholesterol and triglycerides and low HDL-cholesterol ) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial). Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins) when the cholesterol lowering effect of HMG-Coa reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet and oter non-pharmacological treatments (e.g. exercise weight reduction) should be continued during therapy with Tredaptive. NICOTINIC ACID 1000 MG ; LAROPIPRANT 20 MG BLISTER ACLAR/ALUMINIUM 14 CAPSULES; BLISTER ACLAR/ALUMINIUM 28 CAPSULES; BLISTER ACLAR/ALUMINIUM 56 CAPSULES DEXXON LTD 141-71-31856-00 DEXXON LTD PER OS Contraceptive. GESTODENE 0.075 MG ; ETHINYLESTRADIOL 0.03 MG BLISTER PVC/PVDC/ALUMINIUM 3 x 21 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 21 TABLETS ʪʥʺʮʣʥʮʲ YAEL 20/10/2009 141-73-31893-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-74-31893-11 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-75-32997-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ GLAXO GROUP LIMITED, UK ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ GLAXO SMITH KLINE (ISRAEL) LTD NASAL ʸʩʹʫʺʭʹ AVAMYS ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 01/11/2009 141-80-31837-00 AVAMYS (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older. FLUTICASONE FUROATE 27.5 MCG/DOSE BOTTLE AMBER GLASS TYPE I 30 SINGLE DOSE; BOTTLE AMBER GLASS TYPE I 60 SINGLE DOSE; BOTTLE AMBER GLASS TYPE I 120 SINGLE DOSE GENZYME IRELAND LTD GENZYME ISRAEL LTD PER OS CHOLESTAGEL 03/11/2009 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-81-31865-00 Cholestagel co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol (LDL-C) levels ʤʩʥʥʺʤ in patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Cholestagel as monotherapy is indicated as adjunctive therapy to diet for teduction of elevated total and LDL- cholesterol in patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. COLESEVELAM HYDROCHLORIDE 625 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE HDPE 180 TABLETS NOVARTIS CONSUMER HEALTH SA, NUTRITION CONSUMER HEALTH PER OS EXCEDRIN 04/11/2009 SWITZERLAND For temporary relief of the pain of headache, mild to moderate pain associated with migraine headache, pain of menstrual descomfort and pain accompanied by fever. PARACETAMOL 250 MG ; ACETYLSALICYLIC ACID 250 MG ; CAFFEINE 65 MG BLISTER PVC/PCTFE/PVC 10 CAPLETS; BOTTLE HDPE 50 CAPLETS; BOTTLE HDPE 24 CAPLETS TEVA PARENTERAL MEDICINES INC, USA SALOMON,LEVIN & ELSTEIN LTD I.V EPOPROSTENOL TEVA ® 0.5 MG 05/11/2009 Epoprostenol Teva is indicated for the long-term intravenous treatment of primary arterial pulmonary hypertension and arterial pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA class III and class IV patients who do not respond to conventional therapy. EPOPROSTENOL AS SODIUM 0.5 MG VIAL GLASS TYPE I 2 x 50 ML; VIAL GLASS TYPE I 1 x 0.5 MG MERCK SHARP & DOHME B.V, HOLLAND MERCK SHARP & DOHME ISRAEL LTD PER OS ARCOXIA 30 MG TABLETS 10/11/2009 Arcoxia tablets are indicated for the symptomatic relief of osteoarthritis (OA). ETORICOXIB 30 MG BLISTER POLYAMIDE/ALUMINUM/PVC 2 TABLETS; BLISTER POLYAMIDE/ALUMINUM/PVC 7 TABLETS; BLISTER POLYAMIDE/ALUMINUM/PVC 28 TABLETS ASTRA ZENECA UK LIMITED ASTRA ZENECA ISRAEL LTD PER OS SEROQUEL XR 200 MG 15/11/2009 141-82-31782-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-84-32941-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-86-31986-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 141-90-31974-00 Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes. ʭʩʡʩʫʸʮ QUETIAPINE FUMARATE 200 MG BLISTER PVC/PCTFE 100 TABLETS; BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 60 TABLETS; BLISTER PVC/PCTFE 50 ʺʥʦʩʸʠ TABLETS ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ASTRA ZENECA UK LIMITED ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ASTRA ZENECA ISRAEL LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ SEROQUEL XR 300 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 15/11/2009 141-91-31975-00 Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes. QUETIAPINE FUMARATE 300 MG ʭʩʡʩʫʸʮ BLISTER PVC/PCTFE 100 TABLETS; BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 50 TABLETS; BLISTER PVC/PCTFE 60 ʺʥʦʩʸʠ TABLETS ASTRA ZENECA UK LIMITED ASTRA ZENECA ISRAEL LTD PER OS SEROQUEL XR 50 MG 15/11/2009 141-89-31973-00 Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes. ʭʩʡʩʫʸʮ QUETIAPINE FUMARATE 50 MG BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 50 TABLETS; BLISTER PVC/PCTFE 60 TABLETS; BLISTER PVC/PCTFE 100 ʺʥʦʩʸʠ TABLETS ASTRA ZENECA UK LIMITED ASTRA ZENECA ISRAEL LTD PER OS SEROQUEL XR 400 MG 15/11/2009 141-92-31976-00 Seroquel XR is indicated for the treatment of schizophrenia. Seroquel XR is effective in preventing relapse in stable schizophrenic patients who have been maintained on Seroquel ʤʩʥʥʺʤ XR. Seroquel XR is indicated for the treatment of moderate to severe manic episodes in the framework of bipolar disorder. Seroquel XR is indicated for the treatment of major depressive episodes in bipolar desorder. Seroquel XR is not indicated for the prevention of recurrence of manic or depressive episodes. QUETIAPINE FUMARATE 400 MG ʭʩʡʩʫʸʮ BLISTER PVC/PCTFE 100 TABLETS; BLISTER PVC/PCTFE 10 TABLETS; BLISTER PVC/PCTFE 30 TABLETS; BLISTER PVC/PCTFE 50 TABLETS; BLISTER PVC/PCTFE 60 ʺʥʦʩʸʠ TABLETS MEDIMMUNE LLC, USA ASTRA ZENECA ISRAEL LTD INTRANASAL FLUMIST 16/11/2009 141-88-32988-00 FluMist is a vaccine indicated for the active immunization of individuals 2- 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in ʤʩʥʥʺʤ the vaccine. B/BRISBANE/60/2008 7±0.5 log 10FFU / 0.2 ML ; A/BRISBANE/59/2007 (H1N1) 7±0.5 log 10FFU / 0.2 ML ; A/BRISBANE/10/2007 (H3N2) 7±0.5 log 10FFU / 0.2 ML ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ SPRAY UNIT DOSE GLASS TYPE I 10 DOSES BAUSCH & LOMB INCORPORATED, USA SALOMON,LEVIN & ELSTEIN LTD OCULAR LOTEMAX ® 16/11/2009 141-93-31617-00 Lotemax is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as ʤʩʥʥʺʤ allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to otain an advisable diminution in edema and inflammation. Lotemax is less effective than prednisolone acetate 1 % in two 28 day controlled clinical studies in acute anterior uveitis, where 72 % of patients treated with Lotemax experienced resolution of anterior chamber cells, compared to 87 % of patients treated with prednisolone acetate 1 % . The incidence of patients with clinically significant increases in IOP (> or = 10 mmHg) was 1 % with Lotemax adn 6 % with prednisolone acetate 1 %. Lotemax should not be used in patients who require a more potent corticosteroid for this indication. Lotemax is also indicated for the treatment of post - operative inflammation following ocular surgery. LOTEPREDNOL ETABONATE 5 MG / 1 ML ʭʩʡʩʫʸʮ BOTTLE LPDE 1 x 15 ML; BOTTLE LPDE 1 x 2.5 ML; BOTTLE LPDE 1 x 5 ML; BOTTLE LPDE 1 x 10 ML ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ORION CORPORATION ORION NOVARTIS PHARMA SERVICES AG PER OS STALEVO 200/50/200 MG PHARMA,FINLAND Treatment of patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 22/11/2009 141-94-31768-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ LEVODOPA 200 MG ; ENTACAPONE 200 MG ; CARBIDOPA 50 MG (AS MONOHYDRATE) BOTTLE HDPE 10 TABLETS; BOTTLE HDPE 30 TABLETS; BOTTLE HDPE 100 TABLETS ANBEX INC, USA GOLDEN HEART F.M.C.G. LTD PER OS IOSAT 01/12/2009 Iosat (Potassium iodide tablets USP) is a thyroid blocking medicine that is used in a nuclear radiation emergency only. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ POTASSIUM IODIDE 130 MG STRIPS ALUMINIUM 14 TABLETS SANOFI WINTHROP INDUSTRIE, FRANCE SANOFI - AVENTIS ISRAEL LTD PER OS AMBIEN CR 6.25 MG 01/12/2009 For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). BLISTER PVC/ALUMINIUM 28 TABLETS SANOFI - AVENTIS ISRAEL LTD PER OS AMBIEN CR 12.5 MG 01/12/2009 For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). BLISTER PVC/ALUMINIUM 28 TABLETS PHARMASWISS ISRAEL LTD PER OS SWISS RELIEF DUAL RELEASE 142-06-31834-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ZOLPIDEM TARTRATE 12.5 MG TEMMLER WERKE GmbH, GERMANY 142-05-31833-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ZOLPIDEM TARTRATE 6.25 MG SANOFI WINTHROP INDUSTRIE, FRANCE 142-03-31868-00 03/12/2009 142-10-31815-00 As a non-steroidal anti-inflamatory analgesic in symptomatic management of rheumatoid arthritis osteoarthritis and ankylosying spondylitis acute musculo-skeletal disorders such ʤʩʥʥʺʤ as periarthritis tendenitis tensynovitis bursitis sprains strains and dislocations relief of pain in fractures low back pain acute gout psoriatic arthropathy. In the management of pain and inflammation associated with orthopaedic dental and minor surgery. DICLOFENAC SODIUM 75 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVC/PVDC 4 CAPSULES; BLISTER PVC/PVDC 20 CAPSULES; BLISTER PVC/PVDC 56 CAPSULES LES LABORATOIRES SERVIER INDUST., MEDILINE LTD. FRANCE Treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures. PER OS PROTELOS 06/12/2009 STRONTIUM RANELATE 2 G SACHET PAPER/PE/ALU/PE 7 ; SACHET PAPER/PE/ALU/PE 14 ; SACHET PAPER/PE/ALU/PE 28 ; SACHET PAPER/PE/ALU/PE 56 ; SACHET PAPER/PE/ALU/PE 100 ; SACHET PAPER/PE/ALU/PE 84 ʪʥʺʮʣʥʮʲ 142-09-31882-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ BEUTLICH L.P. PHARMACEUTICALS, USA ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ LEVY DENTAL CO. LTD ʯʥʰʩʮʺʸʥʶ ORAL ʸʩʹʫʺʭʹ HURRICAINE ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 06/12/2009 142-11-32950-00 +XUULFDLQHLVGHVLJQHGIRUDQ\GHQWDOSURFHGXUHLQZKLFKWRSLFDODQHVWKHVLDLVGHVLUHG ʤʩʥʥʺʤ +XUULFDLQHLVDOVRXVHGIRUWHPSRUDU\UHOLHIRIRFFDVLRQDOPLQRULUULWDWLRQDQGSDLQDVVRFLDWHGZLWKFDQNHUVRUHVVRUHPRXWKDQGWKURDWPLQRULQMXU\RIWKHPRXWKDQGJXPVFDXVHG E\GHQWXUHVRURUWKRGHQWLFDSSOLDQFHV BENZOCAINE 20%W/W ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE HDPE 28.35 G JANSSEN CILAG S.P.A., ITALY J-C HEALTH CARE LTD PER OS PREZISTA 400 MG 10/12/2009 142-12-31999-00 Prezista , co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection ʤʩʥʥʺʤ for over 18 years of age. DARUNAVIR AS ETHANOLATE 400 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE HDPE 60 TABLETS JANSSEN CILAG S.P.A., ITALY J-C HEALTH CARE LTD PER OS PREZISTA 600 MG 10/12/2009 142-13-32000-00 Prezista , co-administered with 100 mg ritonavir (Prezista/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection ʤʩʥʥʺʤ for over 18 years of age. DARUNAVIR AS ETHANOLATE 600 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE HDPE 60 TABLETS TARO PHARMACEUTICAL INDUSTRIES LTD TARO PHARMACEUTICAL INDUSTRIES LTD PER OS NORMALAX 14/12/2009 For the treatment of constipation. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ POLYETHYLENE GLYCOL 3350 100 %W/W BOTTLE HDPE 150 ML; BOTTLE HDPE 400 ML DR.R.PFLEGER CHEMISCHE FABRIK GmbH TEC-O-PHARM-LIBRA LTD PER OS SPASMEX 30 14/12/2009 For the treatment of vegetative bladder dysfunction accompanied by urgency and/or frequency and/or urinary incontinence. BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS MEDICI LTD I.M 142-14-31805-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ TROSPIUM CHLORIDE 30 MG SANOFI PASTEUR LTD, CANADA 142-15-32012-00 ADACEL 14/12/2009 142-16-32020-00 Active booster immunization against diphtheria, tetanus and pertussis in children, adolescents and adults aged 4 to 64 years. Adacel is not indicated for treating diseases caused by ʤʩʥʥʺʤ B.pertussis, C.diphtheriae or C. tetani infections. PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE ; FILAMENTOUS HAEMOGGLUTININ (FHA) 5 MCG/DOSE ; FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE ; PERTACTIN (PRN) ʭʩʡʩʫʸʮ 3 MCG/DOSE ; DIPHTHERIA TOXOID 2LF / 1 DOSES; TETANUS TOXOID 5LF / 1 DOSES VIAL GLASS TYPE I 1 x 0.5 ML; VIAL GLASS TYPE I 5 x 0.5 ML ʺʥʦʩʸʠ ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ TEVA PHARMACEUTICAL INDUST.LTD PER OS ʸʩʹʫʺʭʹ REPAGLINIDE TEVA ® 0.5 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 21/12/2009 142-17-32017-00 Treatment of type II diabetes. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ REPAGLINIDE 0.5 MG BLISTER ALUMINIUM /ALUMINIUM 90 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS REPAGLINIDE TEVA ® 1 MG 21/12/2009 Treatment of type II diabetes. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ REPAGLINIDE 1 MG BLISTER ALUMINIUM /ALUMINIUM 90 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS REPAGLINIDE TEVA ® 2 MG 21/12/2009 Treatment of type II diabetes. 142-19-32019-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ REPAGLINIDE 2 MG BLISTER ALUMINIUM /ALUMINIUM 90 TABLETS PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD I.V OXALIPLATIN PWD TEVA ® 24/12/2009 2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU $GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU 7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU OXALIPLATIN 50MG/VIAL PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ I.V OXALIPLATIN TEVA ® 31/12/2009 2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU $GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU 7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU OXALIPLATIN 5MG/ML 142-23-31784-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 4 ML; VIAL GLASS TYPE I 1 x 10 ML; VIAL GLASS TYPE I 1 x 20 ML; VIAL GLASS TYPE I 1 x 40 ML TEVA PHARMACEUTICAL INDUST.LTD 142-20-31785-00 ʤʩʥʥʺʤ VIAL GLASS TYPE I 1 x 50 MG TEVA PHARMACEUTICAL INDUSTRIES LTD 142-18-32018-00 OCULAR For the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. BRIMONIDINE TARTRATE 0.15%W/V BOTTLE LDPE 5 ML ʪʥʺʮʣʥʮʲ BRIMONIDINE TEVA ® 31/12/2009 142-22-31742-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʯʸʶʩ ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ HOFFMANN LA ROCHE LTD, SWITZERLAND ROCHE PHARMACEUTICAL (ISRAEL) I.V ACTEMRA 20MG/ML 01/01/2010 142-21-31931-00 LTD Actemra (tocilizumab) is indicated for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who had an inadequate response to one ʤʩʥʥʺʤ or more DMARDs (Disease modifying antirhematic drugs) or TNF antagonists or in whom DMARDs cannot be used. Actemra can be used alone or in combination with methotrexate or other DMARDs. TOCILIZUMAB 20 MG/ML ʭʩʡʩʫʸʮ VIAL GLASS TYPE I 1 x 4 ML; VIAL GLASS TYPE I 4 x 4 ML; VIAL GLASS TYPE I 1 x 10 ML; VIAL GLASS TYPE I 4 x 10 ML; VIAL GLASS TYPE I 1 x 20 ML; VIAL GLASS TYPE I 4 x 20 ML N.V. ORGANON, NETHERLANDS SCHERING PLOUGH ISRAEL AG I.V BRIDION 06/01/2010 Reversal of neuromuscular blockade induced by rocuronium or vecuronium. VIAL GLASS TYPE I 10 x 2 ML; VIAL GLASS TYPE I 10 x 5 ML TEVA PHARMACEUTICAL INDUST.LTD 142-27-31898-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ SUGAMMADEX 100 MG/ML TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʦʩʸʠ PER OS ETODOLAC ER TEVA ® 400 MG 06/01/2010 142-24-31718-00 For the management of signs and symptoms of osteoarthritis and rehumatoid arthritis. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 14 TABLETS; BLISTER PVDC/ALUMINIUM 20 TABLETS; ʺʥʦʩʸʠ ETODOLAC 400 MG BLISTER PVDC/ALUMINIUM 21 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS ETODOLAC ER TEVA ® 600 MG 06/01/2010 142-26-31720-00 For the management of signs and symptoms of osteoarthritis and rehumatoid arthritis. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 14 TABLETS; BLISTER PVDC/ALUMINIUM 20 TABLETS; ʺʥʦʩʸʠ ETODOLAC 600 MG BLISTER PVDC/ALUMINIUM 21 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS For the management of signs and symptoms of osteoarthritis and rehumatoid arthritis. ETODOLAC ER TEVA ® 500 MG 06/01/2010 142-25-31719-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 14 TABLETS; BLISTER PVDC/ALUMINIUM 20 TABLETS; ʺʥʦʩʸʠ ETODOLAC 500 MG BLISTER PVDC/ALUMINIUM 21 TABLETS ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ TEVA PHARMACEUTICAL INDUST.LTD PER OS ʸʩʹʫʺʭʹ LETROZOLE TEVA ® ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 06/01/2010 142-28-31878-00 Letrozole teva tablets is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whom hormone receptor status cannot be determined, locally advanced or metastatic breast cancer: Letrozole teva is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. LETROZOLE 2.5 MG BLISTER PVDC/ALUMINIUM 28 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS CHEMIPHARMA S.P.A., ITALY ROMAT LTD, RAMAT-GAN PER OS IN DRINKING TAF 25 % VETERINARY 10/01/2010 WATER For the treatment of bacterial diseases of the respiratory and intestinal system, caused especially by Gram-positive and Gram-negative micro-organisms, mycoplasmas and clamydiae in broilers. THIAMPHENICOL 250MG/ML BOTTLE POLYETHYLENE 1000 ML; CAN POLYETHYLENE 5000 ML CHATTEM GLOBAL CONSUMER PRODUCTS LTD Treatment of dandruff and seborrhoea capitis. MEDILINE LTD. TOPICAL SELSUN SHAMPOO 2.5 % W/V 10/01/2010 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-30-92419-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-29-32028-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ SELENIUM SULFIDE 25 MG/ML BOTTLE PEHD 150 ML; BOTTLE PEHD 50 ML; BOTTLE PEHD 100 ML WEST PHARMA- PROD. DE ESPEC. BIOAVENIR LTD PER OS LETROZOLE FARMOZ 10/01/2010 142-31-31918-00 FARMACEUT.S.A. Letrozole Farmoz tablets is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whom hormone receptor status cannot be determined, ʤʩʥʥʺʤ locally advanced or metastatic breast cancer: Letrozole Farmoz is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. LETROZOLE 2.5 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER ALUMINIUM 30 TABLETS TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS For the treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence. TOLTERODINE TARTRATE 2 MG BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BLISTER PVDC/ALUMINIUM 30 CAPSULES ʪʥʺʮʣʥʮʲ TOLTERODINE E.R. TEVA ® 2 MG 12/01/2010 142-32-31790-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ TEVA PHARMACEUTICAL INDUST.LTD PER OS ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ TOLTERODINE E.R. TEVA ® 4 MG 12/01/2010 For the treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency or urge incontinence. BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BLISTER PVDC/ALUMINIUM 30 CAPSULES J-C HEALTH CARE LTD S.C STELARA 45 MG 13/01/2010 STELARA™ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients (18 years or older) who have failed to,or have contraindication to or who are intolerant to other systemic therapies including ciclosporin,methotrexate and psoralen plus U.V (PUVA). USTEKINUMAB 45 MG / 0.5 ML VIAL GLASS 1 x 0.5 ML TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD 142-33-31791-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ TOLTERODINE TARTRATE 4 MG CILAG AG, SWITZERLAND ʸʩʹʫʺʸʴʱʮ PER OS MYCOPHENOLATE TEVA ® 500 13/01/2010 MG Prophylaxis of rejection in renal allograft recepients, in patients receiving allogenic cardiac transplants and in allogenic hepatic transplants. Mycophenolate Teva should be used concomitantly with ciclosporin and corticosteroids. MYCOPHENOLATE MOFETIL 500 MG 142-36-32021-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-37-32978-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ BLISTER PVDC/ALUMINIUM 60 TABLETS; BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 50 TABLETS ʺʥʦʩʸʠ BAYER ANIMAL HEALTH GmbH, GERMANY LIDORR CHEMICALS LTD DERMAL ADVOCATE FOR DOGS 13/01/2010 142-38-92431-00 VETERINARY For dogs suffering from or at risk from mixed parasitic infections : For the treatment and prevention of flea infestation (Ctenocephalides felis) treatment of biting lice (Trichodectes ʤʩʥʥʺʤ canis) treatment of ear mit infestation (Otodectes cynotis) sarcoptic mange (caused by sarcoptes scabiei var. canys) demodicosis ( caused by demodex canis) prevention of heartworm disease (L3 and L4 larvae of dirofilaria immitis) treatment of angiostrongylus vasorum adn treatment of infections with gastrointestinal nematodes (L4 larve immature adults and adults of toxocara canis ancylostoma caninum and uncinaria stenocephala adults of toxascaris leonina and trichuris vulpis). The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). ʭʩʡʩʫʸʮ IMIDACLOPRID 100 MG/ML ; MOXIDECTIN 25 MG/ML TUBE POLYPROPYLENE 6 x 0.4 ML; TUBE POLYPROPYLENE 3 x 2.5 ML; TUBE POLYPROPYLENE 3 x 4 ML; TUBE POLYPROPYLENE 6 x 4 ML; TUBE POLYPROPYLENE ʺʥʦʩʸʠ 6 x 2.5 ML; TUBE POLYPROPYLENE 3 x 1 ML; TUBE POLYPROPYLENE 6 x 1 ML; TUBE POLYPROPYLENE 3 x 0.4 ML BAYER ANIMAL HEALTH GmbH, GERMANY LIDORR CHEMICALS LTD DERMAL ADVOCATE FOR CATS 13/01/2010 142-39-92432-00 VETERINARY For cats suffering from or at risk from mixed parasitic infections : For the treatment and prevention of flea infestation (Ctenocephalides felis) treatment of ear mit infestation ʤʩʥʥʺʤ (Otodectes cynotis) prevention of heartworm disease (L3 and L4 larvae of dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larve immature adults and adults of toxocara cati ancylostoma tubaeforne). The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). IMIDACLOPRID 100 MG/ML ; MOXIDECTIN 10 MG/ML ʭʩʡʩʫʸʮ TUBE POLYPROPYLENE 3 x 0.8 ML; TUBE POLYPROPYLENE 6 x 0.4 ML; TUBE POLYPROPYLENE 6 x 0.8 ML; TUBE POLYPROPYLENE 3 x 0.4 ML ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʯʸʶʩ ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD I.V ʸʩʹʫʺʭʹ OXALIPLATIN PWD TEVA ® ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 14/01/2010 142-34-33148-00 2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU $GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU 7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU OXALIPLATIN 20MG/VIAL ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 20 MG PHARMACHEMIE BV, HOLLAND (TEVA GROUP) SALOMON,LEVIN & ELSTEIN LTD I.V OXALIPLATIN PWD TEVA ® 14/01/2010 2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLO)8DQGIROLQLFDFLG)$LVLQGLFDWHGIRU $GMXYDQWWUHDWPHQWRIVWDJH,,,'XNH V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU 7UHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU OXALIPLATIN 100MG/VIAL ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 100 MG SAM-ON LTD., BAT-YAM SAM-ON LTD PER OS FOLEX 400 NEW 19/01/2010 For the prevention and treatment of iron deficiency anemia and for maintaining the level of folic acid particular in pregnancy. FOLIC ACID 400 MCG ; FERROUS FUMARATE 100 MG BLISTER PVC/ALUMINIUM 1000 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 90 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS NOVARTIS PHARMA SCHWEIZ AG., NUTRITION CONSUMER HEALTH TOPICAL FENLIPS 20/01/2010 SWITZERLAND For the topical treatment for cold sores (oral herpes). PENCICLOVIR 10MG/G TUBE ALUMINIUM 2 G; TUBE ALUMINIUM 2 G H.LUNDBECK A/S, DENMARK LUNDBECK ISRAEL LTD 142-35-33149-00 PER OS CIPRAMIL 40 MG TABLETS 21/01/2010 For the treatment of states of depresion and panic disorder. Antipyretic, analgesic. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-41-31798-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-50-32025-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ CITALOPRAM AS HYDROBROMIDE 40 MG BLISTER PVC/PVDC/ALUMINIUM 98 TABLETS; CONTAINER POLYPROPYLENE 100 TABLETS; CONTAINER POLYPROPYLENE 250 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 14 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 56 TABLETS PERRIGO COMPANY, USA PERRIGO ISRAEL AGENCIES LTD PER OS MACCABIMOL KID DROPS 142-40-33082-00 21/01/2010 142-51-33085-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ PARACETAMOL 80 MG / 0.8 ML DROPER BOTTLE POLYETHYLENE 30 ML ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ LES LABORATOIRES SERVIER INDUST., MEDILINE LTD. PER OS CORALAN 5 MG FRANCE Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers. ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 21/01/2010 142-49-32001-00 IVABRADINE AS HYDROCHLORIDE 5 MG BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 56 TABLETS; BLISTER PVC/ALUMINIUM 84 TABLETS; BLISTER PVC/ALUMINIUM 98 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS; BLISTER PVC/ALUMINIUM 112 TABLETS LES LABORATOIRES SERVIER INDUST., MEDILINE LTD. PER OS CORALAN 7.5 MG 21/01/2010 FRANCE Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers. IVABRADINE AS HYDROCHLORIDE 7.5 MG ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-48-32002-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVC/ALUMINIUM 112 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 56 TABLETS; BLISTER PVC/ALUMINIUM 84 TABLETS; BLISTER PVC/ALUMINIUM 98 TABLETS; BLISTER PVC/ALUMINIUM 100 TABLETS DOPHARMA B.V., NETHERLANDS M.P.VET LTD PER OS IN DRINKING DOXYCYCLINE 50 % WSP 21/01/2010 142-47-92426-00 WATER VETERINARY For the treatment of infections diseases caused by bacteria sensitive to Doxycycline in broilers. Respiratory infections caused by the following microorganisms : mycoplasma spp., ʤʩʥʥʺʤ e.coli and haemophilus paragallinarum, enteritis caused by clostridium spp. and clostridium colinum. DOXYCYCLINE AS HYCLATE 50% ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ SECURITAINER POLYPROPYLENE 1 KG UNICHEM LABORATORIES LIMITED, INDIA ABIC MARKETING LTD PER OS ALFUZOSIN ER TEVA ® 10 MG 21/01/2010 Treatment of certain functional symptoms of benign prostatic hypertrophy particularly if surgery has to be delayed for some reason. Adjuvant treatment to a catheter in acute urinary retention related to benign prostatic hypertrophy. ALFUZOSIN HYDROCHLORIDE 10 MG BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS IVAX PHARMACEUTICALS UK ( TEVA SALOMON,LEVIN & ELSTEIN LTD RUNCORN) Bronchial asthma especially in cases where other therapy is insufficient or insuitable. INHALATION BUDESONIDE STERINEBS TEVA ® 0.5 MG/2 ML 28/01/2010 BUDESONIDE 0.25 MG / 1 ML AMPOULES POLYETHYLENE 35 x 2 ML; AMPOULES POLYETHYLENE 40 x 2 ML; AMPOULES POLYETHYLENE 45 x 2 ML; AMPOULES POLYETHYLENE 50 x 2 ML; AMPOULES POLYETHYLENE 5 x 2 ML; AMPOULES POLYETHYLENE 10 x 2 ML; AMPOULES POLYETHYLENE 15 x 2 ML; AMPOULES POLYETHYLENE 20 x 2 ML; AMPOULES POLYETHYLENE 25 x 2 ML; AMPOULES POLYETHYLENE 30 x 2 ML ʪʥʺʮʣʥʮʲ 142-46-31943-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-43-33002-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ HOSPIRA AUSTRALIA PTY LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ NOVAPHARMA LTD I.V ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ OXALIPLATIN HOSPIRA 5 MG/ML 28/01/2010 - 100 MG 2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLODQGIROLQLFDFLG)$LVLQGLFDWHGIRU DGMXYDQWWUHDWPHQWRIVWDJH,,,'XNH V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU WUHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU OXALIPLATIN 100MG/VIAL NOVAPHARMA LTD ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ I.V OXALIPLATIN HOSPIRA 5 MG/ML 28/01/2010 - 50 MG 2[DOLSODWLQLQFRPELQDWLRQZLWKIOXRURXUDFLODQGIROLQLFDFLG)$LVLQGLFDWHGIRU DGMXYDQWWUHDWPHQWRIVWDJH,,,'XNH V&FRORQFDQFHUDIWHUFRPSOHWHUHVHFWLRQRIWKHSULPDU\WXPRXU WUHDWPHQWRIPHWDVWDWLFFRORUHFWDOFDQFHU OXALIPLATIN 50MG/VIAL SANOFI - AVENTIS ISRAEL LTD 142-44-31644-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 50 MG SANOFI WINTHROP INDUSTRIE, FRANCE 142-45-31645-00 ʤʩʥʥʺʤ VIAL GLASS TYPE I 1 x 100 MG HOSPIRA AUSTRALIA PTY LTD ʸʩʹʫʺʸʴʱʮ PER OS MULTAQ 28/01/2010 To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent artrial fibrillation (AF) or atrial flutter ( AFL ) , with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e. age > 70, hypertension, diabetes , prior cerebrovascular accident, left atrial diameter > or = 50 mm or left ventricular ejection fraction [ LVEF] < 40 % ), who are in sinus rhythm or who will be cardioverted. DRONEDARONE 400 MG 142-42-32977-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 50 TABLETS WYETH GRANGE CASTLE (WGC), IRELAND NEOPHARM LTD I.V ENBREL 25 MG PRE-FILLED 01/02/2010 142-52-31949-00 SYRINGE Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless ʤʩʥʥʺʤ contraindicated) has been inadequate. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. Enbrel is indicated for the treatment of active polyarticular-course juvenile chronic arthritis in chilldren aged 4 to 17 years who have had an inadequate response to or who have proved intolerant of methotrexate. Enbrel has not been studied in children aged less than 4 years. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ETANERCEPT 25 MG/DOSE ʭʩʡʩʫʸʮ SYRINGE PREFILLED GLASS TYPE I 24 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 4 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 8 x 0.5 ML ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ WYETH GRANGE CASTLE (WGC), IRELAND ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ NEOPHARM LTD ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ I.V ENBREL 50 MG PRE-FILLED 01/02/2010 142-53-31950-00 SYRINGE Enbrel is indicated for the treatment of active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless ʤʩʥʥʺʤ contraindicated) has been inadequate. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. Enbrel is indicated for the treatment of active polyarticular-course juvenile chronic arthritis in chilldren aged 4 to 17 years who have had an inadequate response to or who have proved intolerant of methotrexate. Enbrel has not been studied in children aged less than 4 years. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ETANERCEPT 50 MG/DOSE ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ SYRINGE PREFILLED GLASS TYPE I 12 x 1 ML; SYRINGE PREFILLED GLASS TYPE I 2 x 1 ML; SYRINGE PREFILLED GLASS TYPE I 4 x 1 ML LILLY S.A., SPAIN ELI LILLY ISRAEL LTD PER OS EFFIENT 10 MG 03/02/2010 142-56-32011-00 (IILHQWFRDGPLQLVWHUHGZLWKDFHW\OVDOLF\OLFDFLG$6$LVLQGLFDWHGIRUWKHSUHYHQWLRQRIDWKHURWKURPERWLFHYHQWVLQSDWLHQWVZLWKDFXWHFRURQDU\V\QGURPHLHXQVWDEOHDQJLQDQRQ ʤʩʥʥʺʤ 67VHJPHQWHOHYDWLRQP\RFDUGLDOLQIDUFWLRQ>8$167(0,@RU67VHJPHQWHOHYDWLRQP\RFDUGLDOLQIDUFWLRQ>67(0,@XQGHUJRLQJSULPDU\RUGHOD\HGSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQ 3&, 7KHLQFUHDVHGHIILFDF\VKRXOGEHEDODQFHGZLWKWKHLQFUHDVHGULVNLQSDWLHQWVZLWKEOHHGLQJWHQGHQF\ LQWKRVHZKRKDG7,$&9$LQWKHSDVWDQGLQWKRVHDERYHWKHDJHRIDQGDZHLJKWEHORZNJ PRASUGREL AS HYDROCHLORIDE 10 MG BLISTER COLD FORM FOIL (CFF) 56 TABLETS; BLISTER COLD FORM FOIL (CFF) 14 TABLETS; BLISTER COLD FORM FOIL (CFF) 6 TABLETS; BLISTER COLD FORM FOIL (CFF) 28 TABLETS; BLISTER COLD FORM FOIL (CFF) 30 TABLETS LILLY S.A., SPAIN ELI LILLY ISRAEL LTD PER OS EFFIENT 5 MG 03/02/2010 ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-55-32010-00 (IILHQWFRDGPLQLVWHUHGZLWKDFHW\OVDOLF\OLFDFLG$6$LVLQGLFDWHGIRUWKHSUHYHQWLRQRIDWKHURWKURPERWLFHYHQWVLQSDWLHQWVZLWKDFXWHFRURQDU\V\QGURPHLHXQVWDEOHDQJLQDQRQ ʤʩʥʥʺʤ 67VHJPHQWHOHYDWLRQP\RFDUGLDOLQIDUFWLRQ>8$167(0,@RU67VHJPHQWHOHYDWLRQP\RFDUGLDOLQIDUFWLRQ>67(0,@XQGHUJRLQJSULPDU\RUGHOD\HGSHUFXWDQHRXVFRURQDU\LQWHUYHQWLRQ 3&, 7KHLQFUHDVHGHIILFDF\VKRXOGEHEDODQFHGZLWKWKHLQFUHDVHGULVNLQSDWLHQWVZLWKEOHHGLQJWHQGHQF\ LQWKRVHZKRKDG7,$&9$LQWKHSDVWDQGLQWKRVHDERYHWKHDJHRIDQGDZHLJKWEHORZNJ PRASUGREL AS HYDROCHLORIDE 5 MG ʭʩʡʩʫʸʮ BLISTER COLD FORM FOIL (CFF) 6 TABLETS; BLISTER COLD FORM FOIL (CFF) 14 TABLETS; BLISTER COLD FORM FOIL (CFF) 28 TABLETS; BLISTER COLD FORM FOIL (CFF) 30 TABLETS; BLISTER COLD FORM FOIL (CFF) 56 TABLETS GENZYME CORPORATION, USA GENZYME ISRAEL LTD S.C MOZOBIL 03/02/2010 Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly. PLERIXAFOR 20 MG ML VIAL GLASS TYPE I 1 x 2 ML ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ 142-58-32938-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ BAYER SCHERING PHARMA AG, GERMANY ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ BAYER ISRAEL LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ XARELTO 10 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 03/02/2010 142-57-31927-00 Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. RIVAROXABAN 10 MG BLISTER PVC/PVDC/ALUMINIUM 5 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 10 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 100 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 5 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 10 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 30 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 100 TABLETS BAUSCH & LOMB INCORPORATED, USA SALOMON,LEVIN & ELSTEIN LTD OCULAR ZYLET 03/02/2010 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-61-31618-00 =\OHWLVLQGLFDWHGIRUVWHURLGUHVSRQVLYHLQIODPPDWRU\RFXODUFRQGLWLRQVIRUZKLFKDFRUWLFRVWHURLGLVLQGLFDWHGDQGZKHUHVXSHUILFLDOEDFWHULDORFXODULQIHFWLRQRUDULVNRIEDFWHULDO ʤʩʥʥʺʤ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¤DQG6HSLGHUPLGLVFRDJXODVHSRVLWLYHDQGFRDJXODVHQHJDWLYHLQFOXGLQJSHQLFLOOLQUHVLVWDQWVWUDLQV6WUHSWRFRFFLLQFOXGLQJVRPHRIWKH*URXS $EHWDKHPRO\WLFVSHFLHVVRPHQRQKHPRO\WLFVSHFLHVDQGVRPH6WUHSWRFRFFXVSQHXPRQLDH3VHXGRPRQDVDHUXJLQRVD(VFKHULFKLDFROL.OHEVLHOODSQHXPRQLDH(QWHUREDFWHU DHURJHQHV3URWHXVPLUDELOLV0RUJDQHOODPRUJDQLLPRVW3URWHXVYXOJDULVVWUDLQV+DHPRSKLOXVLQIOXHQ]DHDQG+DHJ\SWLXV0RUD[HOODODFXQDWD$FLQHWREDFWHUFDOFRDFHWLFXVDQG VRPH1HLVVHULDVSHFLHV TOBRAMYCIN 3MG/ML ; LOTEPREDNOL ETABONATE 5MG/ML ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BOTTLE LDPE 1 x 10 ML; BOTTLE LDPE 1 x 2.5 ML; BOTTLE LDPE 1 x 5 ML H.LUNDBECK A/S, DENMARK LUNDBECK ISRAEL LTD PER OS EBIXA TABLETS 20 MG 03/02/2010 Treatment of patient with moderate to severe Alzheimer's disease. MEMANTINE HYDROCHLORIDE 20 MG BLISTER PVC/PE/PVDC/AL 840 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 14 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 28 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 42 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 49 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 56 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 70 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 84 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 98 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 100 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 112 TABLETS; BLISTER POLYPROPYLENE/ALUMINIUM 840 TABLETS; BLISTER PVC/PE/PVDC/AL 14 TABLETS; BLISTER PVC/PE/PVDC/AL 28 TABLETS; BLISTER PVC/PE/PVDC/AL 42 TABLETS; BLISTER PVC/PE/PVDC/AL 49 TABLETS; BLISTER PVC/PE/PVDC/AL 56 TABLETS; BLISTER PVC/PE/PVDC/AL 70 TABLETS; BLISTER PVC/PE/PVDC/AL 84 TABLETS; BLISTER PVC/PE/PVDC/AL 98 TABLETS; BLISTER PVC/PE/PVDC/AL 100 TABLETS; BLISTER PVC/PE/PVDC/AL 112 TABLETS ʪʥʺʮʣʥʮʲ 142-62-32007-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ SANOFI PASTEUR S.A., FRANCE ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ MEDICI LTD ʯʥʰʩʮʺʸʥʶ I.M ʸʩʹʫʺʭʹ ADACEL POLIO ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 03/02/2010 142-60-31938-00 Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in subjects aged 3 years and over as a booster following primary immunisation . Adacel polio is not ʤʩʥʥʺʤ indicatd for primary immunisation. Adacel polio is not indicated for treating diseases caused by B. pertussis, C.Diphtheriae or c. tetani or by poliomyelitis infections. FIMBRAE TUPES 2 + 3 (FIM) 5 MCG/DOSE ; PERTUSSIS TOXOID VACCINE 2.5 MCG/DOSE ; FILAMENTOUS HAEMOGGLUTININ (FHA) 5 MCG/DOSE ; PERTACTIN (PRN) ʭʩʡʩʫʸʮ 3 MCG/DOSE ; DIPHTHERIA TOXOID 2LF / 1 DOSES; TETANUS TOXOID 5LF / 1 DOSES; INACTIVATED POLIO VIRUS (IPV) TYPE 1 40DU/DOSE ; INACTIVATED POLIO VIRUS (IPV) TYPE 2 8DU/DOSE ; INACTIVATED POLIO VIRUS (IPV) TYPE 3 32DU/DOSE SYRINGE PREFILLED GLASS TYPE I 20 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 1 x 0.5 ML; SYRINGE PREFILLED GLASS TYPE I 10 x 0.5 ML ʺʥʦʩʸʠ TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS RAMIPRIL TEVA ® 2.5 MG 03/02/2010 142-59-31880-00 Hypertension congestive heart failure reduction of mortality in patients after MI with left ventricular dysfunction For reducing the risk of myocardial infarction stoke cardiovascular ʤʩʥʥʺʤ death or need for revascularization procedures in patients over 55 years or more who have clinical evidence of cardiovascular disease (previous MI unstable angina or multivessel CABG or multivessel PTCA) stroke or peripheral vascular disease. Also for reducing the risk of myocardial infarction stroke cardiovascular death or need for revascularization procedures in diabetic patients of 55 years or more who have one or more of the following clinical findings : hypertension (systolic blood pressure > 160 mmHg or diastolic pressure > 90 mmHg) high total cholesterol (>5.2 mmol/L) low HDL ( <0.9 mmol/L) current smoker known microalbuminuria clinical evidence of previous vascular disease. Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1g/day. RAMIPRIL 2.5 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS WYETH PHARMACEUTICALS INC., USA NEOPHARM LTD I.V BENEFIX 2000 IU/VIAL 08/02/2010 142-66-31926-00 Benefix is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or christmas disease), including control and ʤʩʥʥʺʤ prevention of bleeding in surgical settings, in previously treated patients (PTP) and previously untreated patients (PUP). Benefix is not indicated for the treatment of other factor deficiencies (e.g. factors II,VII, and X)' nor for the treatment of hemophilia A patients with inhibitors to factor VIII, nor for the reversal of coumarin-induced anticoagulation, nor for the treatment of bleeding due to low levels of liver-dependent coagulation factors. COAGULATION FACTOR IX RECOMBINANT-RFIX 2000 IU ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 10 ML VETOQUINOL, FRANCE LINEVITZ ELIEZER PER OS DOLPAC 25 VETERINARY 11/02/2010 For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematodes and cestode species : Nemtodes : toxocara canis toxocaris leonine ancylostoma caninum uncinaria stenocephala trichuris vulpis. Cestodes : Dipylidum caninum taenia spp. OXANTEL AS EMBONATE 500.7 MG ; PYRANTEL EMBONATE 124.85 MG ; PRAZIQUANTEL 125 MG BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS VETOQUINOL, FRANCE LINEVITZ ELIEZER PER OS DOLPAC 10 VETERINARY 11/02/2010 For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematodes and cestode species : Nemtodes : toxocara canis toxocaris leonine ancylostoma caninum uncinaria stenocephala trichuris vulpis. Cestodes : Dipylidum caninum taenia spp. OXANTEL AS EMBONATE 200.28 MG ; PYRANTEL EMBONATE 49.94 MG ; PRAZIQUANTEL 50 MG BLISTER PVC/ALUMINIUM 60 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 6 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS ʪʥʺʮʣʥʮʲ 142-77-92433-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-76-92430-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ BLUEPHARMA INDUSTRIA FARMACEUT.S.A., RAFA LABORATORIES LTD PER OS ACROSE 50 PORTUGAL Treatment of non-insulin dependent diabetes mellitus (NIDDM) in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 11/02/2010 142-78-31978-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ACARBOSE 50 MG BLISTER PVC/PE/PVDC/AL 30 TABLETS BLUEPHARMA INDUSTRIA FARMACEUT.S.A., RAFA LABORATORIES LTD PER OS ACROSE 100 PORTUGAL Treatment of non-insulin dependent diabetes mellitus (NIDDM) in patients inadequately controlled on diet alone, or on diet and oral hypoglycaemic agents. 11/02/2010 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ACARBOSE 100 MG BLISTER PVC/PE/PVDC/AL 30 TABLETS SYNTHON B.V., NETHERLANDS INOVAMED LTD PER OS 142-79-31979-00 ANASTROZOLE INOVAMED 1 MG 11/02/2010 142-73-31916-00 Treatment of advanced breast cancer in post menopausal women. Efficay has not been demonstrated in estrogen receptor negative patients unless they had a previous positive ʤʩʥʥʺʤ clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen. ANASTROZOLE 1 MG ʭʩʡʩʫʸʮ BLISTER PVC/PE/PVDC 500 TABLETS; BLISTER PVC/PE/PVDC 10 TABLETS; BLISTER PVC/PE/PVDC 14 TABLETS; BLISTER PVC/PE/PVDC 20 TABLETS; BLISTER ʺʥʦʩʸʠ PVC/PE/PVDC 28 TABLETS; BLISTER PVC/PE/PVDC 30 TABLETS; BLISTER PVC/PE/PVDC 50 TABLETS; BLISTER PVC/PE/PVDC 56 TABLETS; BLISTER PVC/PE/PVDC 60 TABLETS; BLISTER PVC/PE/PVDC 84 TABLETS; BLISTER PVC/PE/PVDC 90 TABLETS; BLISTER PVC/PE/PVDC 98 TABLETS; BLISTER PVC/PE/PVDC 100 TABLETS; BLISTER PVC/PE/PVDC 300 TABLETS RAFA LABORATORIES LTD, JERUSALEM RAFA LABORATORIES LTD PER OS SBT 8 11/02/2010 142-75-31780-00 Substitution treatment for opioid dependence within a framework of medical, social and psychological treatment. BUPRENORPHINE AS HYDROCHLORIDE 8 MG BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 7 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS RAFA LABORATORIES LTD, JERUSALEM RAFA LABORATORIES LTD PER OS SBT 2 11/02/2010 Substitution treatment for opioid dependence within a framework of medical, social and psychological treatment. BUPRENORPHINE AS HYDROCHLORIDE 2 MG BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 7 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS ʪʥʺʮʣʥʮʲ ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-74-31779-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ RECKITT BENCKISER HEALTHCARE RECKITT BENCKISER (NEAR EAST) LTD PER OS NUROFEN SODIUM IBUPROFEN 11/02/2010 142-71-31929-00 INTERNATIONAL LTD, UK 256 MG For the symptomatic relief of mild to moderate pain, such as hedache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, the pain of non-serious arthritis, ʤʩʥʥʺʤ migraine, cold and flu symptoms, sore throat and fever. IBUPROFEN SODIUM 256 MG ʭʩʡʩʫʸʮ BLISTER PVC/ALUMINIUM 24 TABLETS; BLISTER PVC/ALUMINIUM 2 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 32 TABLETS; BLISTER PVC/ALUMINIUM 36 TABLETS; BLISTER PVC/ALUMINIUM 48 TABLETS; BLISTER PVC/ALUMINIUM 96 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 4 TABLETS; BLISTER PVC/ALUMINIUM 5 TABLETS; BLISTER PVC/ALUMINIUM 6 TABLETS; BLISTER PVC/ALUMINIUM 8 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 12 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 16 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS RECKITT BENCKISER HEALTHCARE RECKITT BENCKISER (NEAR EAST) LTD PER OS NUROFEN SODIUM IBUPROFEN 11/02/2010 INTERNATIONAL LTD, UK 512 MG For the symptomatic relief of mild to moderate pain, such as hedache, backache, period pain, dental pain, neuralgia, rheumatic and muscular pain, the pain of non-serious arthritis, migraine, cold and flu symptoms, sore throat and fever. IBUPROFEN SODIUM 512 MG ʺʥʦʩʸʠ 142-72-31944-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ BLISTER PVC/ALUMINIUM 96 TABLETS; BLISTER PVC/ALUMINIUM 2 TABLETS; BLISTER PVC/ALUMINIUM 3 TABLETS; BLISTER PVC/ALUMINIUM 4 TABLETS; BLISTER ʺʥʦʩʸʠ PVC/ALUMINIUM 5 TABLETS; BLISTER PVC/ALUMINIUM 6 TABLETS; BLISTER PVC/ALUMINIUM 8 TABLETS; BLISTER PVC/ALUMINIUM 10 TABLETS; BLISTER PVC/ALUMINIUM 12 TABLETS; BLISTER PVC/ALUMINIUM 14 TABLETS; BLISTER PVC/ALUMINIUM 15 TABLETS; BLISTER PVC/ALUMINIUM 16 TABLETS; BLISTER PVC/ALUMINIUM 18 TABLETS; BLISTER PVC/ALUMINIUM 20 TABLETS; BLISTER PVC/ALUMINIUM 24 TABLETS; BLISTER PVC/ALUMINIUM 28 TABLETS; BLISTER PVC/ALUMINIUM 30 TABLETS; BLISTER PVC/ALUMINIUM 32 TABLETS; BLISTER PVC/ALUMINIUM 36 TABLETS; BLISTER PVC/ALUMINIUM 48 TABLETS BRISTOL MYERS SQUIBB SPA, ITALY BRISTOL-MYERS SQUIBB (ISRAEL) PER OS ABILIFY 30 MG 11/02/2010 142-70-33000-00 LIMITED Abilify is indicated for the treatment of schizophrenia. And for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode ʤʩʥʥʺʤ in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. ARIPIPRAZOLE 30 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS BRISTOL MYERS SQUIBB SPA, ITALY BRISTOL-MYERS SQUIBB (ISRAEL) PER OS ABILIFY 5 MG 11/02/2010 142-68-32994-00 LIMITED Abilify is indicated for the treatment of schizophrenia. And for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode ʤʩʥʥʺʤ in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. ARIPIPRAZOLE 5 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS SANOFI AVENTIS US LLC, USA SANOFI - AVENTIS ISRAEL LTD PER OS Seasonal allergic rhinitis: For the relief of symptoms associated with seasonal allergic rhinitis in children 3 to 11 years of age. FEXOFENADINE HYDROCHLORIDE 6 MG/ML BOTTLE PET 30 ML; BOTTLE PET 150 ML; BOTTLE PET 300 ML ʪʥʺʮʣʥʮʲ TELFAST SUSPENSION 14/02/2010 142-80-31980-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ GLAXO SMITH KLINE BIOLOGICALS S.A ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ GLAXO SMITH KLINE (ISRAEL) LTD ʯʥʰʩʮʺʸʥʶ I.M ʸʩʹʫʺʭʹ SYNFLORIX ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 16/02/2010 142-81-32006-00 Active immunisation of infants and children from 6 weeks up to 2 years of age against invasive disease and acute otitis media caused by Streptococcus pneumoniae serotypes 1,4,5, ʤʩʥʥʺʤ 6B, 7F, 9V, 14, 18C, 19F, and 23F. PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19 F 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 1 MCG / 0.5 ML; PNEUMOCOCCAL ʭʩʡʩʫʸʮ POLYSACCHARIDE SEROTYPE 4 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 1 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C 3 MCG / 0.5 ML; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F 1 MCG / 0.5 ML VIAL GLASS TYPE I 100 x 1 ML; SYRINGE PREFILLED GLASS 10 x 0.5 ML; VIAL GLASS TYPE I 1 x 0.5 ML; VIAL GLASS TYPE I 10 x 0.5 ML; VIAL GLASS TYPE I 100 x 0.5 ʺʥʦʩʸʠ ML; SYRINGE PREFILLED GLASS 1 x 0.5 ML; SYRINGE PREFILLED GLASS 10 x 0.5 ML; SYRINGE PREFILLED GLASS 1 x 0.5 ML PFIZER ITALIA S.R.L., ITALY PFIZER PHARMACEUTICALS ISRAEL PER OS SUTENT 37.5 MG 17/02/2010 142-82-32953-00 LTD 6XWHQWLVLQGLFDWHGIRUWKHWUHDWPHQWRIJDVWURLQWHVWLQDOVWURPDOWXPRUDIWHUGLVHDVHSURJUHVVLRQRQRULQWROHUDQFHWRLPDWLQLEPHV\ODWH ʤʩʥʥʺʤ 6XWHQWLVLQGLFDWHGIRUWKHWUHDWPHQWRIDGYDQFHGUHQDOFHOOFDUFLQRPD SUNITINIB AS MALATE 37.5 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVC/ALUMINIUM 7 CAPSULES; BLISTER PVC/ALUMINIUM 28 CAPSULES; BOTTLE HDPE 30 CAPSULES GENERICS LTD, ENGLAND GENMEDIX PER OS TAMSULOSIN MERCK 0.4 MG 17/02/2010 Treatment of functional symptoms of benign prostatic hyperplasia (BPH). TAMSULOSIN HYDROCHLORIDE 0.4 MG BLISTER PVC/PE/PVDC 14 CAPSULES; BLISTER PVC/PE/PVDC 5 CAPSULES; BLISTER PVC/PE/PVDC 7 CAPSULES; BLISTER PVC/PE/PVDC 10 CAPSULES SAM-ON LTD., BAT-YAM SAM-ON LTD RECTAL GLYCERIN FORTE SUPPOSITORIES 18/02/2010 For relief of constipation. STRIPS FOIL 10 SUPPOSITORIES; STRIPS FOIL 20 SUPPOSITORIES; STRIPS FOIL 100 SUPPOSITORIES; STRIPS FOIL 500 SUPPOSITORIES J-C HEALTH CARE LTD I.V YONDELIS ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-84-32039-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ GLYCERIN 3.2G JANSSEN PHARMACEUTICA N.V.,BELGIUM 142-83-31512-00 18/02/2010 Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. 142-85-31830-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ TRABECTEDIN 1 MG/VIAL VIAL GLASS TYPE I 1 x 1 MG ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ NOVARTIS PHARMA STEIN AG, SWITZERLAND NOVARTIS PHARMA SERVICES AG PER OS ʸʩʹʫʺʭʹ AFINITOR 10 MG ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 22/02/2010 142-87-32046-00 Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ EVEROLIMUS 10 MG BLISTER PA/AL/PVC 30 TABLETS NOVARTIS PHARMA STEIN AG, SWITZERLAND NOVARTIS PHARMA SERVICES AG PER OS AFINITOR 5 MG 22/02/2010 Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib. ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ EVEROLIMUS 5 MG BLISTER PA/AL/PVC 30 TABLETS RECKITT BENCKISER HEALTHCARE INT. LTD, RECKITT BENCKISER (NEAR EAST) LTD UK For the symptomatic treatment of mild to moderate pain. For the symptomatic treatment of fever. RECTAL NUROFEN SUPPOSITORIES 60 MG 02/03/2010 BLISTER PE/ALUMINIUM 20 SUPPOSITORIES; BLISTER PE/ALUMINIUM 1 SUPPOSITORIES RECTAL NUROFEN FOR CHILDREN SUPPOSITORIES 125 MG 02/03/2010 BLISTER PE/ALUMINIUM 1 SUPPOSITORIES; BLISTER PE/ALUMINIUM 20 SUPPOSITORIES NASAL NASIVIN 0.05 % 04/03/2010 Relief of nasal congestion, which is a result of common colds, sinusitis, hay fever or allergies of the upper respiratory system. BOTTLE PLASTIC 10 ML NASAL For temporary relief of nasal congestion due to cold or sinusitis or allergies of the upper respiratory tract. OXYMETAZOLINE HYDROCHLORIDE 0.5 MG/ML BOTTLE PLASTIC 10 ML ʪʥʺʮʣʥʮʲ 142-91-31857-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ OXYMETAZOLINE HYDROCHLORIDE 0.5 MG/ML MERCK SELBSTMEDIKATION GmbH, GERMANY NAVEH PHARMA LTD 142-89-32016-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ IBUPROFEN 125 MG MERCK SELBSTMEDIKATION GmbH, GERMANY NAVEH PHARMA LTD 142-88-31900-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ IBUPROFEN 60 MG RECKITT BENCKISER HEALTHCARE INT. LTD, RECKITT BENCKISER (NEAR EAST) LTD UK For the symptomatic treatment of muld to moderate pain. For the symptomatic treatment of fever. 142-86-32045-00 NASIVIN 0.025 % 04/03/2010 142-90-31858-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ AMGEN EUROPE B.V., NETHERLANDS ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ AMGEN EUROPE B.V. I.V. INFUSION ʸʩʹʫʺʭʹ VECTIBIX 20 MG/ML ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 04/03/2010 142-92-32951-00 Monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine, oxaliplatin, and ʤʩʥʥʺʤ irinorecan - containing chemotherapy regimens. PANITUMUMAB 20 MG / 1 ML ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 20 ML; VIAL GLASS TYPE I 1 x 5 ML; VIAL GLASS TYPE I 1 x 10 ML RANBAXY UK LTD CTS LTD PER OS SERTRALINE 50 MG TABLETS 07/03/2010 For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertaline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes. SERTRALINE AS HYDROCHLORIDE 50 MG BLISTER PVC/PVDC/ALUMINIUM 100 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 20 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 50 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 98 TABLETS RANBAXY UK LTD CTS LTD PER OS SERTRALINE 100 MG TABLETS 07/03/2010 For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertaline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes. SERTRALINE AS HYDROCHLORIDE 100 MG BLISTER PVC/PVDC/ALUMINIUM 100 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 20 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 28 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 30 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 50 TABLETS; BLISTER PVC/PVDC/ALUMINIUM 98 TABLETS BOEHRINGER INGELHEIM PHARMA GmbH & RAFA LABORATORIES LTD PER OS PRADAXA 110 08/03/2010 CO.KG Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. 142-93-31678-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-94-31679-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-96-32974-00 ʤʩʥʥʺʤ DABIGATRAN ETEXILATE 110 MG ʭʩʡʩʫʸʮ BOTTLE POLYPROPYLENE 10 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 10 CAPSULES; BOTTLE POLYPROPYLENE 30 CAPSULES; BOTTLE POLYPROPYLENE 60 ʺʥʦʩʸʠ CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 60 CAPSULES BOEHRINGER INGELHEIM PHARMA GmbH & RAFA LABORATORIES LTD PER OS PRADAXA 75 08/03/2010 CO.KG Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery. DABIGATRAN ETEXILATE 75 MG BLISTER ALUMINIUM /ALUMINIUM 10 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 30 CAPSULES; BOTTLE POLYPROPYLENE 10 CAPSULES; BOTTLE POLYPROPYLENE 30 CAPSULES; BOTTLE POLYPROPYLENE 60 CAPSULES; BLISTER ALUMINIUM /ALUMINIUM 60 CAPSULES TEVA PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUST.LTD PER OS TAMOXIFEN TEVA ® 10 MG 09/03/2010 For the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities. TAMOXIFEN AS CITRATE 10 MG BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 100 TABLETS; BLISTER PVDC/ALUMINIUM 250 TABLETS ʪʥʺʮʣʥʮʲ 142-95-32973-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 142-97-33083-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TEVA PHARMACEUTICAL INDUSTRIES LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ TEVA PHARMACEUTICAL INDUST.LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 09/03/2010 142-98-33084-00 TAMOXIFEN TEVA ® 20 MG For the palliative treatment of breast cancer generally in post menopausal women, either alone or in combination with other modalities. TAMOXIFEN AS CITRATE 20 MG BLISTER PVDC/ALUMINIUM 10 TABLETS; BLISTER PVDC/ALUMINIUM 30 TABLETS; BLISTER PVDC/ALUMINIUM 100 TABLETS; BLISTER PVDC/ALUMINIUM 250 TABLETS JERINI AG, GERMANY MEDISON PHARMA LTD S.C FIRAZYR 30 MG 11/03/2010 Symptomatic treatment of acute attacks of hereditary angioedima (HAE) in adults (with C1 -esterase-inhibitor deficiency). SYRINGE PREFILLED GLASS TYPE I 1 x 3 ML DEVRIES & CO. LTD PER OS ASPIRIN CARDIO 15/03/2010 The primary prevention of coronary heart disease in patients at increased risk and the secondary prevention of thrombotic cerebrovascular or cardiovascular disease. BLISTER POLYPROPYLENE/ALUMINIUM 3 x 10 TABLETS BIOAVENIR LTD I.V ACYCLOVIR BIOAVENIR 143-06-31982-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ACETYLSALICYLIC ACID 100 MG LABORATORY REIG JOFRE S.A., SPAIN 142-99-33003-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ ICATIBANT AS ACETATE 30 MG / 3 ML BAYER BITTERFELD GmbH, GERMANY ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 16/03/2010 143-05-31907-00 For the treatment of Herpes Simplex infections and severe intial genital herpes in the non immunocompromised. For the prophylaxis of Herpes Simplex infections in immuneʤʩʥʥʺʤ compromised patients. In the treatment of Varicella zoster infections. For Herpes Simplex Encephalitis. For the treatment of herpes simplex infection in the neonate and infant up to 3 months of age. ACYCLOVIR 250 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE II 5 x 10 ML; VIAL GLASS TYPE II 50 x 10 ML WEST PHARMA- PROD. DE ESPEC. BIOAVENIR LTD PER OS ALENDRONATE BIOAVENIR 16/03/2010 FARMACEUT.S.A. Alendronate Bioavenir is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures) . ALENDRONIC ACID AS SODIUM 70 MG TRIHYDRATE BLISTER ALUMINIUM 12 TABLETS; BLISTER ALUMINIUM 2 TABLETS; BLISTER ALUMINIUM 4 TABLETS; BLISTER ALUMINIUM 8 TABLETS CP-PHARMA GmbH, GERMANY A.VETERINARY SUPPLY LTD 143-03-31906-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ PER OS PREDNISOLON 5 MG 16/03/2010 143-01-92414-00 VETERINARY For use in dogs and cats: - rheumatological/orthopaedic disorders: rheumatoid arthritis arthritis deformans bursitis tendinitis periarthritis. - respiratory disorders allergic ʤʩʥʥʺʤ bronchitis. - gastroenterological disorders chronic active hepatitis. - ophthalmological disorders disorders of the posterior optical segment such as chorioretinitis papillitis optic neuritis. -dermatological disorders anti-inflammatory: pyotraumatic dermatitis allergic dermatitis contact dermatitis urticaria idiopathic seborrhoeic dermatitis acral lick dermatitis juvenile cellulitis. - immunosuppressive lupus erythematosus. PREDNISOLONE 5 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVC/PVDC 10 TABLETS; BOTTLE HDPE 100 TABLETS ʪʥʺʮʣʥʮʲ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ CP-PHARMA GmbH, GERMANY ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ ʯʥʰʩʮʺʸʥʶ A.VETERINARY SUPPLY LTD ʸʩʹʫʺʭʹ ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ PER OS PREDNISOLON 50 MG 16/03/2010 143-04-92415-00 VETERINARY For use in dogs and cats: - rheumatological/orthopaedic disorders: rheumatoid arthritis arthritis deformans bursitis tendinitis periarthritis. - respiratory disorders allergic ʤʩʥʥʺʤ bronchitis. - gastroenterological disorders chronic active hepatitis. - ophthalmological disorders disorders of the posterior optical segment such as chorioretinitis papillitis optic neuritis. -dermatological disorders anti-inflammatory: pyotraumatic dermatitis allergic dermatitis contact dermatitis urticaria idiopathic seborrhoeic dermatitis acral lick dermatitis juvenile cellulitis. - immunosuppressive lupus erythematosus. PREDNISOLONE 50 MG ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ BLISTER PVC/PVDC 10 TABLETS NOVO NORDISK A/S, DENMARK NOVO NORDISK LTD S.C VICTOZA 18/03/2010 )RUWKHWUHDWPHQWRIDGXOWVZLWKW\SHGLDEHWHVPHOOLWXVWRDFKLHYHJO\FHPLFFRQWURO LQFRPELQDWLRQZLWK 0HWIRUPLQRUDVXOSKRQ\OXUHDLQSDWLHQWVZLWKLQVXIILFLHQWJO\FHPLFFRQWUROGHVSLWHPD[LPDOWROHUDWHGGRVHRIPRQRWKHUDS\ZLWKPHQWIRUPLQRUVXOSKRQ\OXUHD 0HWIRUPLQDQGVXOSKRQ\OXUHDRUPHWIRUPLQDQGWKLD]ROLGLQHGLRQHLQSDWLHQWVZLWKLQVXIILFLHQWJO\FHPLFFRQWUROGHVSLWHGXDOWKHUDS\ LIRAGLUTIDE 6.0MG/ML ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ PRE FILLED PEN GLASS TYPE I 2 x 3 ML V.M.D. N.V., BELGIUM UDIM PHARMACY I.M; I.V TILOVETO - 20 VETERINARY 143-07-32987-00 25/03/2010 Infectious diseases in cattle caused by Gram-positive bacteria and mycoplasms sensitive to Tylosine. 143-08-92400-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ TYLOSIN AS TARTRATE 200 MG/ML BOTTLE AMBER GLASS TYPE II 100 ML ORION CORPORATION, FINLAND PFIZER PHARMACEUTICALS ISRAEL I.M; I.V DEXDOMITOR VETERINARY 12/04/2010 143-09-92440-00 LTD Non-invasive mildly to moderately painful procedures and examinations which require restraint sedation and analgesia in dogs and cats. Premedication in cats before induction ʤʩʥʥʺʤ and maintenance of general anaesthesia with ketamine. Deep sedation and analgesia in dogs in concomitant use with butorphanol for medical and minor surgical procedures. Premedication in dogs before induction and maintenance of general anaesthesia. DEXMEDETOMIDINE HYDROCHLORIDE 0.5 MG/ML ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ VIAL GLASS TYPE I 1 x 10 ML TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS STATOR 5 13/04/2010 143-12-33069-00 Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia ) or mixed dyslipidaemia ( type IIb ) as an adjunct to diet when response to diet and ʤʩʥʥʺʤ other non-pharmacological treatments (e.g. exercise weight reduction) is inadequate. Hormozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatment are not appropriate. ROSUVASTATIN AS CALCIUM 5 MG ʭʩʡʩʫʸʮ BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS ʪʥʺʮʣʥʮʲ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ TRIMA ISRAEL PHARM.PROD.MAABAROT LTD ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ UNIPHARM LTD ʯʥʰʩʮʺʸʥʶ PER OS ʸʩʹʫʺʭʹ STATOR 10 ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ 13/04/2010 143-13-31932-00 Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise weight reduction ) is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. ROSUVASTATIN AS CALCIUM 10 MG BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS STATOR 20 13/04/2010 Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise weight reduction ) is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. ROSUVASTATIN AS CALCIUM 20 MG BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS TRIMA ISRAEL PHARM.PROD.MAABAROT LTD UNIPHARM LTD PER OS STATOR 40 13/04/2010 Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise weight reduction ) is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. ROSUVASTATIN AS CALCIUM 40 MG BLISTER ALUMINIUM /ALUMINIUM 30 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 7 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 10 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 14 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 21 TABLETS; BLISTER ALUMINIUM /ALUMINIUM 28 TABLETS EBEWE PHARM GES.m.b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x 10 ML ʪʥʺʮʣʥʮʲ ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 143-14-31933-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 143-15-31934-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ 143-10-33099-00 ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ Ministry of Health Pharmaceutical Administration Drug Registration Department ʯʸʶʩ EBEWE PHARM GES.m.b.H NFG. KG, AUSTRIA ʺʥʠʩʸʡʤʣʸʹʮ ʺʥʧʷʥʸʤʳʢʠ ʭʩʩʠʥʴʸʭʩʸʩʹʫʺʭʥʹʩʸʺʷʬʧʮ ʬʠʸʹʩʺʰʩʣʮ STATE OF ISRAEL ʭʥʹʩʸʬʲʡ PHARMALOGIC LTD ʯʥʰʩʮʺʸʥʶ I.V ʸʩʹʫʺʭʹ GEMCITABIN "EBEWE" 1 G ʭʥʹʩʸʪʩʸʠʺ ʸʩʹʫʺʸʴʱʮ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x 50 ML ʪʥʺʮʣʥʮʲ ʤʩʥʥʺʤ ʭʩʡʩʫʸʮ ʺʥʦʩʸʠ
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