Human Medicines
This area of the website provides information relating to the regulation of human medicines, including access to product information, pharmacovigilance and the directory of relevant agencies.
HUMAN MEDICINES | RECENTLY PUBLISHED
Information on nitrosamines for marketing authorisation holders
modified 03/10/2023
The marketing authorisation holder (MAH) is responsible to keep its product…
modified 03/10/2023
Member: Heili Tikk Alternate: Kairi Laius
State Agency of Medicines 1 Nooruse…
modified 29/09/2023
Referral decisions and new product information changes can be found on:
the…
modified 28/09/2023
Changes to product information following the outcome of imposed…
modified 28/09/2023
List of active substances for which data has been submitted in accordance with…
modified 27/09/2023
Added in September 2023
27 September
NEW - Art. 45 assessment report for…
modified 27/09/2023
Oxycodone End of Procedure: 24/03/2021 Date…
modified 27/09/2023
Referral decisions and new product information changes can be found on:
the…
modified 27/09/2023
Core SmPC/PL - Fludeoxyglucose (18F) - Revised Core SmPC and PL (December 2010)
modified 27/09/2023