What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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16/02/2026
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass bestätigte autochthone Dengue-Fälle in Übersee-Départements Frankreichs verzeichnet wurden.
Referenced at:
Safety warnings
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Blood & Tissue
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16/02/2026
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease
Prevention and Control) that confirmed autochthonous cases of chikungunya have been recorded in oversea departments of France.
16/02/2026
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der ECDC (European Centre for Disease
Prevention and Control) mitgeteilt, dass bestätigte autochthone Chikungunya-Fälle in Übersee-Départements Frankreichs verzeichnet wurden.
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.
Testosterone (topical use) New
PSUR-outcome
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03/02/2026
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) 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.
Nefopam New
PSUR-outcome
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29/01/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.