BfArM - Federal Institute for Drugs and Medical Devices

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78 results

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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.

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.

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.

Iris Meetings – Save the Dates Date: 14. December 2023 Topics: Kodiersysteme Type: News

The dates and information for the next Iris meetings are available.

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.

Information Iris User Group Meeting - April 2024 PDF, 218KB, File is accessible Date: 05. December 2023 Topics: Kodiersysteme Type: Download

Information Iris User Group Meeting - April 2024

Information Iris-11 user Webinar - January 2024 PDF, 136KB, File is accessible Date: 04. December 2023 Topics: Kodiersysteme Type: Download

Information Iris-11 user Webinar - January 2024

Registration form Iris User Group Meeting 2024 PDF, 226KB, File is accessible Date: 04. December 2023 Topics: Kodiersysteme Type: Download

Registration form Iris User Group Meeting 2024

BfArM - Impulse Report 2023 PDF, 3MB, File is accessible Date: 28. November 2023 Type: Download

Hydroxyethyl-starch containing Medicines: Introduction of new measures to protect patients Date: 24. November 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch

The Federal Institute for Drugs and Medical Devices (BfArM) publishes updated information on marketability.