IDMP Term Browser – Identification of Medicinal Products (IDMP) Terminology Browser for the eSubmission in Regulatory Affairs Includes: · eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) · Identification of Medicinal Products (IDMP) · Structured Product Labeling (SPL ) · Stoffkatalog – International List of Substances (ABDA) XEVMPD Routes of Administration Information on the standard route of administration (ROA) controlled vocabulary which is required by the European Medicines Agency (EMA). Term EPIDURAL USE Lang EN Role PT Code ADR00008MIG Type ROA Source EMA EDQM Standard Terms EMA references the European Directorate for the Quality of Medicines & Healthcare (EDQM) concerning Standard Terms. Term Epidural användning Epidural anvendelse Epidural bruk EPIDURAL USE Lang SV DA NO EN Role ST ST ST PT Code 20009000 20009000 20009000 20009000 Type SYN SYN SYN SYN Source EDQM EDQM EDQM EDQM XEVMPD Substances The XEVMPD substance controlled vocabulary (SUB) allows Marketing Authorisation Holders (MAHs) to perform an analysis and plan for the implementation of the substance names in their in-house systems. Term Acetylsalicylic acid Acetylsalicylsäure ACID ACETILSALICILIC (AAS) Lang N/A DE RO Role PT ST ST Lang EN Lang EN Role PT PT Code FR FRA Source EMA FDA The Food and Drug Administration (FDA) requires a Stuctured Product Labeling (SPL) for the registration of medicinal products. The substances (SUB) are to be coded by a UNII code. Term Betamethasone dipropionate Lang EN Role PT Code 826Y60901U Type SUB Source FDA SPL - Drug Route of Administration Terminology Information on the pharmaceutical product route of administration (ROA) in SPL. Term Sublingual Lang EN Role PT Code C38300 Type ROA Source FDA SPL Pharmaceutical Dosage Form Terminology Information on the pharmaceutical product dosage form (PHF) in the SPL. Term TABLET, FILM COATED Lang EN Role PT Code C42931 Type PHF Source FDA SPL Package Type Terminology Information on the pharmaceutical product package type (PAC) in the SPL. Term BOTTLE, GLASS Lang EN Role PT Code C43172 Type PAC Source FDA SPL Unit of Presentation Terminology Code PHF00215MIG Type PHF Source EMA Information on the units of measurement (MEA). Role PT Code 1{BLISTER} Type PRE Source EMA ABDA Stoffkatalog – International Substance List Role PT Type ISO ISO SPL - UNII Substances Role PT Information on unit of presentation (PRE) such as dosage form, package type, and unit of measurement terms. Term PIECE Lang EN Role PT Code C89446 Type PRE Source FDA Code C48152 Type MEA Source FDA Drug Information for Health Care Professionals SPL Unit of Measurement Terminology Information on the MAH´s name and Headquarters ID (ORG) used to send/receive product/safety reports as per the organisation’s profile. Lang EN Lang EN EN Source EMA EMA EMA XEVMPD Company Code Term BOEHRINGER INGELHEIM LTD. Term France France Type SUB SUB SUB XEVMPD Units of Presentation Term blister The Country Code is maintained by ISO International Standards. SPL represents countries with the ISO three letter country codes, whereas XEVMPD requires the two letter version. Code SUB12730MIG SUB12730MIG SUB12730MIG XEVMPD Pharmaceutical Dose Forms Term RECTAL CAPSULE XEVMPD and SPL Country Codes Code ORG8830 Type ORG Source EMA ATC (WHO) Term MICROGRAM Lang EN Role PT The ABDA Stoffkatalog includes data on more than 40.000 ingredients and plants, 65.000 synonyms and 150.000 medicinal products in 54 countries. Term 2-Acetoxybenzoesäure Acetylsalicylic acid Acetylsalicylsäure Aspirin ASS Lang N/A N/A N/A N/A N/A Role SY SY PT SY SY Code 104201 104201 104201 104201 104201 Type SUB SUB SUB SUB SUB Source ABDATA ABDATA ABDATA ABDATA ABDATA The ATC list is published and maintained by the WHO Collaborating Centre for Drug Statistics Methodology Type ATC Code C05AA05 Descr Vasoprotectives Agents for treatment of hemorrhoids and anal fissures for topical use Corticosteroids Betamethasone Contact DACON GmbH Bergstraße 81 61118 Bad Vilbel phone: +49 (0) 61 01 - 12 82 01 fax: +49 (0) 61 01 - 58 29 19 eMail: [email protected] by DACON We network drug information! Services Databases Basic databases (free for health care professionals after registration) DACON Supporting communication interfaces Project management · ASCII · HTML · XML · Individual solutions ABDA-database: Recent News Information on changes in drug prices, new products and food supplements. Archive records date from 1995. DACON: Nutrition Information Nutrition tips for certain risk factors (such as high blood pressure) with suggestions for further reading. MMI: Gelbe Liste Pharmindex Information on German drugs, homeopathic and biological remedies. Reimbursable Devices and Care Aids: REHADAT GKV list of reimbursable devices · Pharmacist software · Submitting XEVMPD and IDMP to EMA · Electronic patient card (EPA) ABDA databases: scientific (fees apply) IDMP Term Browser The Terminology browser helps you navigate the jungle of IDMP required controlled vocabularies of Medicinal Product Information in the EU (eSubmission). Connections · Coding MedDRA · Networking international medicinal products DACON: Pharmaceutical Links Links for further information on the internet. Regulatory databases (fees apply) Project expertise · Coding in eSubmission Global Search activates a free text search among all active databases. · Medical information systems in hospitals · Mobile devices · Cleaning up databases · Surgery administration · Developing data management concepts · Systems for health insurance · Web portals · Web shops · Regulatory information management systems (RIMs) Drug safety with C•A•V•E for all systems Medication Patient Date of birth: Sex: FAM 10.10.1965 female Parabenallergy eliciting substance: Methyl-4-hydroxybenzoat Content service · Recent news about medicines · Regulatory controlled vocabularies (XEVMPD, IDMP, SPL) · Individual solutions Integration of customers’ own databases into [pharmazie.com] network Web services · Catalogue of medicines · Updating of data · Matching XEVMPD and IDMP terminology · C•A•V•E Check · Age · Gender · Diseases · Allergies · Interactions · Food incompabilities · Double medication · Capacity of reaction · Addiction Bisolvon drops against cough (drops, Thomae) Medication FAM Diseases: Parabenallergy, bronchial asthma Medication: ASS 500 Hexal (tablets, Hexal AG), Bisolvon drops against cough (drops, Thomae) ASS 500 Hexal (tablets, Hexal AG) Risk of medical application with bronchial asthma Application only with medical attendance ABDA-database: German Drugs All important details on more than 50.000 German drugs and generics. ABDA-database: International Drugs All important details on more than 120.000 international drugs and generics. ABDA-database: Interactions of German Drugs Interactions among German drugs, substances and food. ABDA-database: Medical Interaction (C•A•V•E) Incompatibility check among a patient's medication and individual risk factors (allergies, atypical medication, etc.). ABDA-database: List of Pharmaceutical Ingredients Information on more than 40.000 ingredients and plants with more than 65.000 synonyms and more than 150.000 drugs in 54 countries. ABDA-database: Dossier on Active Substances Pharmacological and toxicological information concerning ingredients. Codex Galenica (Pharma) Information on all drugs registered in Switzerland. Austria Codex Information system for specialties (SIS), information on all drugs registered in Austria. ROTE LISTE® German drug index (including EU concessions and certain medical products). Check CAVE check conclusion: CAVE Sex Disease Allergy Age INTERACTION ADVICE Substance Double Capacity Addiction medication of reaction Food ABDA databases: economic (fees apply) ABDA-database: Item Master Data (Taxe) All economic data (prices, package sizes, registered numbers for ordering, etc.) on all drugs sold in German pharmacies. Visit us at www.pharmazie.com!