Romania - Important notice to the attention of Marketing Authorisation Holders
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- Name of the medicinal product;
- International Non-Proprietary Name (INN) of the active substance contained in the respective medicinal product;
- Approved therapeutic indication(s);
- Approved presentation forms;
- Registration number in the Register of medicinal products for human use authorised by the Community under the centralised procedure;
- Authorisation date;
- Procedure closure date;
- Type of procedure;
- Procedure number as given by the European Medicines Agency (EMEA);
- Number of the EC decision;
- Historic progress of post-authorisation changes, with approval decisions: variations, renewals, transfers;
- Annexes to decisions:
- Annex I - SPC
- Annex II - Marketing Authorisation Holder and conditions for authorisation
- Annex III – Leaflet and Labelling.
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Links to the EMEA website also enable consultation of European Public Assessment Reports (EPARs) centrally authorised medicinal products.
The NMA also reminds interested parties that medicinal products authorised for marketing or undergoing changes after Romania’s accession to the European Union are provided with Romanian versions of approval decisions and specific annexes.
The NMA undertakes ongoing updating of the Excel table as posted on its website with medicinal products newly authorised for marketing through the centralised procedure.
EC approved changes are made available by means of the link to the Europe
