European Medicines Agency — the EU regulator responsible for the centralized authorisation procedure for medicines.
Once EMA grants marketing authorisation, a medicine is authorised in all 27 EU member states plus Iceland, Liechtenstein, and Norway. National agencies (BfArM in Germany, ANSM in France, CBG/MEB in the Netherlands) handle nationally-authorised medicines and country-specific safety actions.
Compounds where this term is relevant
- Semaglutide · GLP-1 receptor agonist · once-weekly subcutaneous
- Tirzepatide · Dual GIP / GLP-1 receptor agonist · once-weekly subcutaneous
- Tesamorelin · Synthetic GHRH analogue · stimulates pituitary GH release · daily subcutaneous
- Setmelanotide · MC4R-selective melanocortin receptor agonist · daily subcutaneous
Related terms
- FDA · U.S. Food and Drug Administration — the U.S. regulator for food, drugs, biologic…
- INN · International Nonproprietary Name — the unique generic name assigned to a pharma…
- Prescription-only · A regulatory status requiring a valid prescription from a licensed healthcare pr…