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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

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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