BfArM - Federal Institute for Drugs and Medical Devices

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442 results

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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.

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.

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.

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.

Direct Healthcare Professional Communication (DHPC) on fentanyl-containing transdermal patches: late inclusion of a warning on accidental use PDF, 426KB, File is accessible Date: 01. September 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

Marketing authorization holders of fentanyl-containing transdermal patches provide information on the delayed inclusion of an accidental use warning on the outer packaging and, if applicable, the patches sachets.

Information Letter on Zeposia (Ozanimod): Modified dosing recommendation for mild or moderate chronic hepatic impairment (Child-Pugh class A or B) PDF, 134KB, File is accessible Date: 18. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ozanimod

Bristol Myers Squibb provides information on the recommendation for dose reduction in mild or moderate chronic hepatic impairment.

The restrictions on the use of mitomycin preparations from Medac GmbH for intravenous administration are lifted PDF, 484KB, File does not meet accessibility standards Date: 17. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

Medac GmbH informs about the lifting of the restrictions on the use of its mitomycin preparations for intravenous administration.

Direct Healthcare Professional Communication (DHPC) on Voxzogo® (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL PDF, 243KB, File is accessible Date: 01. August 2023 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vosoritide

BioMarin International Limited in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that from August 2023, Voxzogo co-packs will contain new solvent needles and …