BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on melphalan hydrochloride, Melphalan AqVida 90 mg/ml concentrate for solution for infusion: potential risk of overdose due to higher concentration PDF, 477KB, File does not meet accessibility standards Date: 16. December 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: melphalan hydrochloride

AqVida GmbH would like to inform you that Melphalan AqVida 90 mg/ml is a melphalan formulation that is supplied in a single vial.

Updated information Iris Webinar - January 2026 PDF, 139KB, File is accessible Date: 15. December 2025 Type: Download

Updated information Iris Webinar - January 2026

NEW CONTENT, ISSUE 12.2 PDF, 43KB, File does not meet accessibility standards Date: 15. December 2025 Topics: Licensing Type: Download

NEW CONTENT, ISSUE 12.2

Direct Healthcare Professional Communication (DHPC) on intravenous tranexamic acid formulations: Serious, including fatal, adverse reactions due to accidental intrathecal administration PDF, 879KB, File does not meet accessibility standards Date: 11. December 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tranexamic acid

The marketing authorisation holders inform that injectable tranexamic acid formulations are only authorised for intravenous use.

Structure of the BfArM in text form PDF, 172KB, File is accessible Date: 08. December 2025 Topics: About BfArM Type: Download

Structure of the BfArM (date 08.12.2025)

Structure of the BfArM PDF, 168KB, File does not meet accessibility standards Date: 08. December 2025 Topics: About BfArM Type: Download

Structure of the BfArM (date 08.12.2025)

When will devices have to be registered in EUDAMED / when will the use of EUDAMED become mandatory? Date: 01. December 2025 Topics: Medical devices Type: FAQ

Products must continue to be registered in DMIDS until EUDAMED becomes mandatory on 28 May 2026. This will be followed by a six-month transition period, after which all MDR and IVDR products and legacy devices (still on the market on the date of …

Downloads Iris Institute - Terms and conditions for downloading (PDF, 244 kB) PDF, 267KB, File is accessible Date: 01. December 2025 Topics: Kodiersysteme Type: Download

Downloads Iris Institute - Terms and conditions for downloading