What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Sulfamethoxazole, trimethoprim (cotrimoxazole) New
PRAC signal recommendation
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03/06/2025
Risk for Circulatory shock. Further information and amendments to the product information can be found on the EMA website.
messages in brief
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02/06/2025
To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.
Recall
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Medicines
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02/06/2025
Recall due to visible particles in solution
Oxcarbazepine New
PSUR-outcome
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02/06/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
30/05/2025
Antrag auf Ausstellung einer Bestätigung Sachkundige Person, Herstellungsleiter, Kontrolllaborleiter nach der Arzneimittelbetriebsordnung 2009 / TAMBO (F_I220)
Referenced at:
Chlorocresol/chlorhexidine/hexamidine New
PSUR-outcome
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30/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Anastrozole New
PSUR-outcome
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30/05/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
27/05/2025
AGES Standardvorlage englisch other regulatory contact persons other regulatory contact persons Dokument-Nr.: L_LCM_VIE_00QM_Z93_09 valid from: 23.05.2025 1/2 assessment of name of medicinal product p
Referenced at:
26/05/2025
FAQ - reportable qualified persons 1. Which key personnel are companies required to report immediately? 2. Which formal requirements are obligatory for the exercise of the function of the Qualified Pe
23/05/2025
Statistics on reporting New Reports of suspected adverse reactions An adverse reaction to the vaccine is any reaction that is harmful and unintended. Not every sign of illness that occurs in temporal