BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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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.

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 | HES

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

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.

DHPC (Rote-Hand-Brief) on Profact Depot 9.45 mg 3-month implant: Risk of premature implant dissolution/future adjustment of the storage temperature PDF, 142KB, File is accessible Date: 17. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Buserelin

The company Cheplapharm Arzneimittel GmbH informs about an insufficient release of the active substance in the last time fraction (day 78 - 91) of the in vitro dissolution test.

Direct Healthcare Professional Communication (DHPC) on omega-3 fatty acid-containing drugs: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular disease or cardiovascular risk factors PDF, 251KB, File is accessible Date: 16. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: omega-3 fatty acid

The marketing authorisation holders of medicines containing omega-3 fatty acids inform that systematic reviews and meta-analyses of randomised controlled trials show a dose-dependent increased risk of atrial fibrillation.

Azithromycin: re-evaluation of the benefits and risks Date: 10. November 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: azithromycin

EMA’s human medicines committee (CHMP) has started a review of systemic medicines.

Direct Healthcare Professional Communication (DHPC) on topiramate: New restrictions to prevent exposure during pregnancy PDF, 206KB, File is accessible Date: 02. November 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: topiramate

The marketing authorisation holders of medicinal products containing topiramate provide information on the implementation of a pregnancy prevention programme for topiramate.

Ocaliva: review started Date: 13. October 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

EMA’s human medicines committee (CHMP) has started a review of the medicine Ocaliva (obeticholic acid), used to treat adults with primary biliary cholangitis (PBC).

Direct Healthcare Professional Communication (DHPC) on InfectoCillin powder for oral solution: Defective sealing insert in the cap PDF, 152KB, File does not meet accessibility standards Date: 28. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Phenoxymethylpenicillin potassium

The company InfectoPharm Arzneimittel und Consilium GmbH informs about a quality defect of the medicinal products InfectoCillin 400 powder for oral solution, 100 ml and InfectoCillin 500 powder for oral solution, 100 ml due to a defect of the cap.