Up-to-date information from the 19.05.-22.05.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

STILISTISCHE BELANGE Stilistische Belange Dokument-Nr.: L_LCM_VIE_REGA_Z44_08 Gültig ab: 06.06.2025 1/5 Institut LCM Abteilung REGA STILISTISCHE BELANGE Nationale Vorgaben für FI/GI/KE (Produktinforma

Referenced at:

• SmPC and PL

Risk for Circulatory shock. Further information and amendments to the product information can be found on the EMA website.

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  Mustertext Sulfamethoxazol, Trimethoprim | 358 KB
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  Link to the EMA Website

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 due to visible particles in solution

Further information and amendments to the product information in all EU languages are available on the EMA website.

• link
  Link to the EMA Website

Antrag auf Ausstellung einer Bestätigung Sachkundige Person, Herstellungsleiter, Kontrolllaborleiter nach der Arzneimittelbetriebsordnung 2009 / TAMBO (F_I220)

Referenced at:

• FAQ - reportable qualified persons
• FAQ - reportable qualified persons

Further information and amendments to the product information in all EU languages are available on the EMA website.

• link
  Link to the EMA Website

Further information and amendments to the product information in all EU languages are available on the EMA website.

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  Mustertext Anastrozol | 453 KB
• link
  Link to the EMA Website

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:

• How to contact us