What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Vancomycin New
PSUR-outcome
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02/12/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
01/12/2025
Safety features AMVS Implementation of the Counterfeit Medicines Directive - Digital Medicines Security system ensures more safety for Austrian patients The Background of Serialization in Austria and
01/12/2025
Rules of Procedure (in German only) New Current rules of procedure and annex Rules of procedure of the BASG (L_M71) | 99 KB Rules of Procedure of the Federal Office for Safety in Health Care valid fro
01/12/2025
Anlage zu § 1 Abs. 1 der Geschäftsordnung des Bundesamtes für Sicherheit im Gesundheitswesen gültig ab dem 30.11.2025.
Referenced at:
Codeine New
PSUR-outcome
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28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Atenolol New
PSUR-outcome
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28/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dorzolamide/Timolol New
Additional template
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27/11/2025
Further information can be found in the CMDh minutes from october 2025.
Dorzolamide New
PSUR-outcome
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27/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gabapentin New
PSUR-outcome
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27/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
27/11/2025
Gemäß § 8. (2) Gewebevigilanzverordnung ist das BASG dazu verpflichtet, die von der Europäischen Kommission verfasste Zusammenfassung der von den Mitgliedstaaten eingegangenen Berichte zu veröffentlichen (Bericht nur auf englisch verfügbar).
Referenced at: