BfArM - Federal Institute for Drugs and Medical Devices

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818 results

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Direct Healthcare Professional Communication (DHPC) on Forxiga® (Dapagliflozin) 5 mg: the medicinal product should no longer be used for the treatment of Type 1 Diabetes PDF, 194KB, File is accessible Date: 29. October 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dapagliflozin

AstraZeneca, in agreement with the European Medicines Agency (EMA) and the German Federal Institute for Drugs and Medical Devices (BfArM), informs that Forxiga® (dapagliflozin) 5 mg is no longer approved for the treatment of patients with type 1 …

Direct Healthcare Professional Communication (DHPC) on CHAMPIX: batches to be recalled due to presence of N-nitroso-varenicline above the accepted intake limit PDF, 214KB, File is accessible Date: 30. September 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: varenicline

The company Pfizer Pharma GmbH informs that all Champix (varenicline) batches that were found to contain N-nitroso-varenicline above the acceptable level of intake set at EU level are being recalled.

Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives: Prescribing those with the lowest risk of venous thromboembolism and use of the officially mandated education material material. PDF, 321KB, File is accessible Date: 30. September 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: combined hormonal contraceptives

The Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you once again, that combined hormonal contraceptives (CHCs) with the progestogens levonorgestrel, norethisterone or norgestimate have the lowest risk of venous …

Direct Healthcare Professional Communication (DHPC) on Mitem® 20 mg: Restrictions of use for intravenous administration PDF, 125KB, File does not meet accessibility standards Date: 20. September 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mitomycine

Restriction of use due to a possible drug risk during intravenous administration.

Tetrazepam-containing medicines: revocation of approval Date: 19. July 2021 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: tetrazepam

Marketing authorizations for tetrazepam-containing drugs are being revoked because the risk-benefit ratio is unfavorable.

Direct Healthcare Professional Communication (DHPC) on CHAMPIX: Batch recall due to contamination with N-nitroso-varenicline above Pfizer's acceptable daily dose PDF, 71KB, File is accessible Date: 15. July 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Varenicline

The company Pfizer would like to inform that several batches of the drug CHAMPIX are being recalled

Direct Healthcare Professional Communication (DHPC) on ▼Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies with use of tofacitinib relative to TNF-alpha inhibitors PDF, 109KB, File is accessible Date: 06. July 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer Europe MA EEIG provides information about an increased incidence of myocardial infarction with tofacitinib compared with TNF-alpha inhibitors, as well as an increased incidence of malignancy in patients with rheumatoid arthritis (RA) who were …

Basis for the ongoing monitoring and improvement of drug safety Date: 01. July 2021 Topics: Arzneimittelsicherheit Pharmakovigilanz Type: Article

Taking medicine can be associated with certain risks. All medicinal products are carefully monitored after having been placed on the EU market.

Information Letter on Lynparza® 50 mg hard capsules (active ingredient olaparib): discontinuation of production at the end of 2021 PDF, 83KB, File is accessible Date: 29. June 2021 Topics: Pharmakovigilanz Aktuelles Type: Direct Healthcare Professional Communication

Active substance: olaparib

AstraZeneca informs that the production of Lynparza® 50 mg hard capsules (active ingredient: olaparib) will be discontinued at the end of 2021.

Direct Healthcare Professional Communication (DHPC) on Minprostin®, Prepidil®, Propess® (dinoprostone-containing drugs): updates to product information on risk reduction of uterine hyperstimulation, uterine rupture, and fetal/neonatal death. PDF, 295KB, File is accessible Date: 28. June 2021 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dinoprostone

The product information for dinoprostone-containing drugs (Minprostin®, Prepidil®, Propess®) is updated.