BfArM - Federal Institute for Drugs and Medical Devices

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Information Letter on Leqvio 284 mg solution for injection in a pre-filled syringe: Important information regarding instructions for use before injection PDF, 1MB, File is accessible Date: 21. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: inclisiran

The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.

CHMP Meeting Highlights December 2023 Date: 20. December 2023 Topics: Licensing Type: Article

CHMP Meeting Highlights December 2023

Working Parties of the Expert Committees Date: 14. December 2023 Topics: Licensing Type: Article

Working Parties of the Expert Committees

Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis PDF, 325KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs about an updated warning regarding ocular changes.

Expert Committees of the German Pharmacopoeia Date: 14. December 2023 Topics: Licensing Type: Article

Expert Committees of the German Pharmacopoeia

Direct Healthcare Professional Communication (DHPC) on etoposide (not etoposide phosphate): Hypersensitivity reactions with the use of inline filters PDF, 237KB, File is accessible Date: 14. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etoposide

The marketing authorization holders of medicinal products containing etoposide (not etoposide phosphate) inform that there is an increased risk of infusion-related hypersensitivity reactions when using inline filters.

Direct Healthcare Professional Communication (DHPC) on Furosemid-hameln 10 mg/ml (250 mg in 25 ml; 10 x 25 ml ampoules; PZN 16833989): Visible particles PDF, 155KB, File is accessible Date: 12. December 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: furosemide

Furosemide-hameln ampoules may contain isolated visible particles. The batches mentioned should be checked visually before use.

Topiramate-containing medicinal products: Risks associated with the use of topiramate during pregnancy and in women of childbearing age. Date: 01. December 2023 Type: Risk information

Active substance: topiramate

In a decision dated 22 November 2023, the Federal Institute for Drugs and Medical Devices (BfArM) implements the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures - Human (CMDh) of 11 October …

Direct Healthcare Professional Communication (DHPC) on hydroxyethyl starch (HES) solutions for infusion: Measures to minimise risks associated with off-label use PDF, 187KB, File is accessible Date: 21. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The Federal Institute for Drugs and Medical Devices (BfArM) has decided that the conditions for lifting the suspension are meanwhile fulfilled. Infusion solutions containing HES may only be used in the approved indications.

Annual reports Date: 21. November 2023 Topics: About BfArM Type: Article

Annual reports of the Federal Institute for Drugs and Medical Devices