Alkem EMEA-H-A31-1436 - European Medicines Agency
1 April 2016 EMA/239593/2016 Procedure Management and Committees Support Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial estate, Taloja, Dist. Raigad – 410 208, India site between March 2013 and March 2015 Article 31 of Directive 2001/83/EC Procedure number: EMEA/H/A-31/1436 Please note that this draft Annex I may be updated to reflect further information on concerned products/MAHs 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact An agency of the European Union © European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. Member State in Marketing EEA authorisaton holder Bulgaria Krka d.d., Novo mesto Product name Furocef 250 mg film- INN Strength Pharmaceutical Route of form administration Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Riluzole 50 mg Film-coated tablet Oral use coated tablets Bulgaria Krka d.d., Novo mesto Furocef 500 mg filmcoated tablets Croatia Krka - farma d.o.o. Furocef 250 mg filmcoated tablets Croatia Krka - farma d.o.o. Furocef 500 mg filmcoated tablets Czech Republic Alkem Pharma GmbH Riluzole Alkem 50 mg potahované tablety Czech Republic Krka d.d., Novo mesto Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet Oral use Czech Republic Krka d.d., Novo mesto Ricefan 500 mg Cefuroxime 500 mg Film-coated tablet Oral use Estonia Krka d.d., Novo mesto FUROCEF Cefuroxime 250 mg Film-coated tablet Oral use Estonia Krka d.d., Novo mesto FUROCEF Cefuroxime 500 mg Film-coated tablet Oral use France Krka d.d., Novo mesto CEFUROXIME KRKA Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Cefuroxime axetil 250 mg Film-coated tablet Oral use Cefuroxime axetil 500 mg Film-coated tablet Oral use 250 mg, comprimé pelliculé France Krka d.d., Novo mesto CEFUROXIME KRKA 500 mg, comprimé pelliculé Germany Alkem Pharma GmbH Cefuroxim Alkem 250 mg Filmtabletten Germany Alkem Pharma GmbH Cefuroxim Alkem 500 mg Filmtabletten Annex I - List of the medicines affected by the referral EMA/239593/2016 Page 2/5 Member State in Marketing EEA authorisaton holder Germany Alkem Pharma GmbH Product name Riluzol Alkem 50 mg INN Strength Pharmaceutical Route of form administration Riluzole 50 mg Film-coated tablet Oral use Cefuroxime 250 mg Tablet Oral use Cefuroxime 500 mg Tablet Oral use Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Filmtabletten Hungary Krka d.d., Novo mesto Furocef Krka 250 mg tablets Hungary Krka d.d., Novo mesto Furocef Krka 500 mg tablets Latvia Krka d.d., Novo mesto Ricefan 250 mg filmcoated tablets Latvia Krka d.d., Novo mesto Ricefan 500 mg filmcoated tablets Lithuania Krka d.d., Novo mesto Ricefan Cefuroxime 250 mg Film-coated tablet Oral use Lithuania Krka d.d., Novo mesto Ricefan Cefuroxime 500 mg Film-coated tablet Oral use Poland Krka d.d., Novo mesto Furocef Cefuroxime 250 mg Film-coated tablet Oral use Poland Krka d.d., Novo mesto Furocef Cefuroxime 500 mg Film-coated tablet Oral use Portugal Krka d.d., Novo mesto Cefuroxima Krka Cefuroxime axetil 250 mg Film-coated tablet Oral use Portugal Krka d.d., Novo mesto Cefuroxima Krka Cefuroxime axetil 500 mg Film-coated tablet Oral use Romania Krka d.d., Novo mesto CEFUROXIME KRKA Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Cefuroxime 250 mg Film-coated tablet Oral use 250 mg, comprimate Romania Krka d.d., Novo mesto CEFUROXIME KRKA 500 mg, comprimate Slovak Republic Krka d.d., Novo mesto Furocef 250 mg filmom obalené tablety Slovak Republic Krka d.d., Novo mesto Furocef 500 mg filmom obalené tablety Slovenia Krka d.d., Novo mesto Annex I - List of the medicines affected by the referral EMA/239593/2016 Ricefan Page 3/5 Member State in Marketing EEA authorisaton holder Slovenia Krka d.d., Novo mesto Ricefan Cefuroxime Spain Alkem Pharma GmbH Cefuroxima 500 mg Product name Pharmaceutical Route of form administration 500 mg Film-coated tablet Oral use Cefuroxime axetil 500 mg Film-coated tablet Oral use Cefuroxime axetil 250 mg Film-coated tablet Oral use Cefuroxime 250 mg Film-coated tablet Oral use Cefuroxime 500 mg Film-coated tablet Oral use Riluzole 50 mg Film-coated tablet Oral use Cefuroxime axetil 250 mg Film-coated tablet Oral use Cefuroxime axetil 500 mg Film-coated tablet Oral use INN Strength comprimidos recubiertos con película Spain Alkem Pharma GmbH Cefuroxima Alkem 250 mg comprimidos recubiertos con película Spain Krka d.d., Novo mesto Cefuroxima KRKA 250 mg comprimidos recubiertos con película Spain Krka d.d., Novo mesto Cefuroxima KRKA 500 mg comprimidos recubiertos con película Spain Alkem Pharma GmbH Riluzole 50 mg comprimidos recubiertos con película EFG United Kingdom Alkem Pharma GmbH Cefuroxime 250mg film-coated tablets United Kingdom Alkem Pharma GmbH Cefuroxime 500mg film-coated tablets Annex I - List of the medicines affected by the referral EMA/239593/2016 Page 4/5 Member State in Marketing EEA authorisaton holder United Kingdom Alkem Pharma GmbH Product name Riluzole alkem 50 INN Riluzole Strength 50 mg Pharmaceutical Route of form administration Film-coated tablet Oral use mg film-coated tablets Annex I - List of the medicines affected by the referral EMA/239593/2016 Page 5/5
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