What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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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 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:
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:
Pegylated liposomal doxorubicin New
PRAC signal recommendation
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10/02/2026
Risk for Renal-limited thrombotic microangiopathy. Further information and amendments to the product information can be found on the EMA website.
Cefazolin; cefazolin, lidocaine hydrochloride New
PRAC signal recommendation
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10/02/2026
Risk for Kounis syndrome. Further information and amendments to the product information can be found on the EMA website.
Isotretinoin (oral formulations) New
PSUR-outcome
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02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cytarabine New
PSUR-outcome
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02/02/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.
Linezolid New
PSUR-outcome
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30/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.