What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Piritramide New
PSUR-outcome
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03/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Simvastatin (fixed dose combination products) New
Additional template
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03/03/2026
Further information can be found in the CMDh minutes from december 2025.
Blood & Tissue
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03/03/2026
The donor/the donor gametes have been permanently blocked.
03/03/2026
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass die dänischen Gewebebank European Sperm Bank folgende Information übermittelt hat:
Bei einem weiblichen Nachkommen des Samenspenders 8305 Glean wurde kongenitale Muskeldystrophie Typ 1A (MDC1A) diagnostiziert.
Der Spender/die Spendergameten wurden permanent gesperrt.
Referenced at:
Simvastatin New
PSUR-outcome
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02/03/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Recall
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Medicines
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02/03/2026
Recall due to nitrosamine contamination above the permitted daily dose
Illegal websites New
25/02/2026
Illegal websites Illegal medicines are often offered for sale on supposedly trustworthy websites via their webshops. The presentation of the websites often aims to convey that the respective provider
23/02/2026
Institut Surveillance Guideline eService „Inspektionen und Überwachung“ for third country inspections TABLE OF CONTENTS 1 General 2 2 Registration for the eService „Inspektionen und Überwachung“ 3 3 L
Referenced at:
23/02/2026
Institut Überwachung Leitfaden eService Inspektionen und Überwachung Inhalt 1 Allgemeines 2 2 Registrierung für das eService „Inspektionen und Überwachung“ 2 3 Login 4 4 Antrag stellen 4 4.1 Auswahl d
Referenced at:
Recall
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Medicines
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20/02/2026
Recall due to incorrect labelling