What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Niflumic acid New
PSUR-outcome
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03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Blood & Tissue
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03/11/2025
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed autochthonous cases of Chikungunya have been reported in Modena (province of Modena) in Italy.
03/11/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass in Italien, zusätzlich zu den bereits bekannt gegebenen Regionen, bestätigte autochthone Chikungunya-Fälle in Modena (Provinz Modena) verzeichnet wurden.
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Disodium hydrogen phosphate / sodium dihydrogen phosphate, phosphate sodium New
PSUR-outcome
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03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Testosterone (all formulations apart from topical use) New
PSUR-outcome
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03/11/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Blood & Tissue
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03/11/2025
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, further confirmed autochthonous cases of chikungunya have been recorded in Landes, France.
Safety warnings
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Blood & Tissue
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03/11/2025
The Federal Office for Health Safety has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed autochthonous cases of dengue fever have been recorded in the Haute-Garonne department in France.
Botulinum neurotoxin type a (150 kd) free from complexing proteins New
PSUR-outcome
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31/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
30/10/2025
Guideline pharmacovigilance New Guidance notes:Direct Healthcare Professional Communication (DHPC) / Educational Material (EM) (L_Z100) | 1 MB 30/10/2025 Change Version (L_Z100) | 1 MB 30/10/2025
Dexketoprofen / Tramadol New
PSUR-outcome
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30/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.