BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Direct Healthcare Professional Communication (DHPC) on Esbriet®: important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) Date: 29. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Pirfenidone

Roche Pharma Ltd informs about severe cases of drug-induced liver injury (DILI) recently reported using Esbriet® (Pirfenidone).

Direct Healthcare Professional Communication (DHPC) on systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence PDF, 128KB, File is accessible Date: 29. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluoroquinolones

The marketing authorisation holders of fluoroquinolone antibiotics products would like to inform you about the risk of heart valve regurgitation/incompetence associated with fluoroquinolones for systemic and inhalation use.

EU regulators request nitrosamine testing of metformin medicines (CHMP meeting highlights 12-15 October 2020) Date: 16. October 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: metformin

EU regulators request nitrosamine testing of metformin medicines

Dear Doctor Letter (Rote-Hand-Brief) on Kybella® 10 mg/ml solution for injection (deoxycholic acid): risk of injection-site necrosis PDF, 270KB, File is accessible Date: 15. October 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: deoxycholic acid

The Marketing Authorisation Holder (MAH) informs about the risk of injection-site necrosis.

Panexcell Clinical Laboratories Priv. Ltd.: conduct of studies in India Date: 14. October 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: vgarious (in Germany parenteral iron sucrose)

The BfArM has provisionally ordered the suspension of the above-mentioned generic drug approvals in its decision of October 7, 2020.

Remdesivir (Veklury®): PRAC checks signal for kidney damage Date: 06. October 2020 Topics: Pharmakovigilanz Type: Risk information

Active substance: remdesivir

PRAC has begun reviewing a safety signal for acute renal damage in some COVID-19 patients treated with Veklury® (Remdesivir).

Ranitidine: EMA reviews ranitidine-containing drugs based on detection of NDMA Date: 29. September 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ranitidine

The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the temporary suspension of all holders of marketing authorisations for medicinal products containing ranitidine.

Dexamethasone: review of dexamethasone for treating adults with COVID-19 requiring respiratory support Date: 18. September 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: dexamethasone

The European Medicines Agency (EMA) supports the use of dexamethasone in COVID-19 patients on oxygen or artificial respiration.

Leuprorelin-containing depot medicinal products: handling errors with depot formulations Date: 06. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: leuprorelin

With its decision of 29 July 2020, the BfArM implements the unanimous decision of the CMDh of 25 June 2020 for depot drugs containing leuprorelin.

Fluorouracil,capecitabine, tegafur and flucytosine: recommendation for testing and treatment Date: 04. August 2020 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: fluorouracil | capecitabine | tegafur | flucytosine

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission with a notice in the national graduated plan procedure.