What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
For the RSS feed with daily notifications of updates, use the link: RSS feed for “What'sNew”.
Search narrowed by
Recall
|
Medicines
|
10/12/2025
Recall due to contamination with petroleum jelly
Recall
|
Medicines
|
10/12/2025
Recall due to deviations from quality standards at the active ingredient manufacturer
10/12/2025
1225_Register Arzneimittelvermittler.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenz- nummer Betriebsstandort Straße PLZ Ort 484516 AGILIS Trading GmbH Kärntner Str. 26/3 1010 Wien 484493
Referenced at:
Enforcement
|
09/12/2025
Feline infectious peritonitis (FIP) is an infectious disease caused by feline coronavirus and affects exclusively cats. The disease is incurable and usually fatal. Studies are currently investigating the suitability of the active ingredient GS-441524 for the treatment of FIP. However, there is presently no corresponding approved veterinary medicinal product in the EU. The purchase of unapproved (veterinary) medicinal products or active pharmaceutical ingredients, such as GS-441524, for example, via the internet, constitutes a violation of the Austrian Medicines Import Act.
Safety warnings
|
Blood & Tissue
|
09/12/2025
The French authorities have informed the Federal Office for Safety in Health Care that, in addition to the regions already announced, confirmed human WNV infections have been recorded in the département of Corse du Sud.
Trimethoprim (Mono) New
Additional template
|
04/12/2025
Further information regarding SmPC harmonisation are available in Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 14-15 October 2025.
Propylthiouracil New
PSUR-outcome
|
03/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Medical devices
|
02/12/2025
The BASG has announced that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use as from 28 May 2026.
Vancomycin New
PSUR-outcome
|
02/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Codeine New
PSUR-outcome
|
28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.