BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on cyproterone acetate: restrictions in use due to the risk of meningioma PDF, 723KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Cyproteronacetat

The marketing authorisation holders of cyproterone containing medicines would like to inform about the occurrence of meningiomas in association with the use of cyproterone acetate.

Information Letter on Zomacton® (somatropin): change in the trade names of the injection equipment for administering the drugs PDF, 192KB, File is accessible Date: 16. April 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: somatropin

Ferring Arzneimittel GmbH informs that the needle-free injection device ZomaJet 2 Vision for the administration of Zomacton® 4 mg has been renamed ZomaJet 4 and the needle-free injection device ZomaJet Vision X for the administration of …

Direct Healthcare Professional Communication (DHPC) on Trisenox® (arsenic trioxide): risk of medication errors due to the introduction of a 2 mg/ml vial replacing the 1 mg/ml glass vial PDF, 239KB, File is accessible Date: 31. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: arsenic trioxide

The company Teva B.B. informs in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that the Trisenox® (arsenic trioxide) 1 mg/ml 10 ml ampoule (contains 10 mg arsenic …

Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg for uterine fibroids: not to be used during ongoing review of liver injury risk PDF, 255KB, File is accessible Date: 23. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ulipristal acetate

Gedeon Richter Pharma GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that Ulipristal acetate 5 mg is temporarily withdrawn from the market during the ongoing …

Direct Healthcare Professional Communication (DHPC) on Xeljanz® (Tofacitinib): increased risk of venous thromboembolic events and increased risk of serious and fatal infections PDF, 337KB, File is accessible Date: 20. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tofacitinib

Pfizer, in coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), informs that a dose-dependent increased risk of serious venous thromboembolic events has been observed in …

Direct Healthcare Professional Communication (DHPC) on Cytotec® (misoprostol): risks associated with an off-label use for birth initiation PDF, 235KB, File is accessible Date: 16. March 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Misoprostol

The German Federal Institute for Drugs and Medical Devices (BfArM) informs that there are numerous new reports of severe side effects when using Cytotec® outside the approved indication. The drug Cytotec® is not approved for birth initiation.

Information Letter on valproate: restrictions on use and introduction of the contraceptive programme PDF, 821KB, File is accessible Date: 26. February 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: valproate

The marketing authorisation holders Aristo Pharma GmbH, Desitin Arzneimittel GmbH and Sanofi-Aventis Deutschland GmbH will again provide information about restrictions on use and the introduction of the pregnancy prevention programme for …

Direct Healthcare Professional Communication (DHPC) on Linoladiol N® (Estradiol): risks associated with systemic exposure PDF, 701KB, File is accessible Date: 20. February 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: estradiol

Dr. August Wolff GmbH & Co. KG Arzneimittel in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that treatment with Linoladiol N® (containing estradiol 100 …

Direct Healthcare Professional Communication (DHPC) on▼Picato® (ingenol mebutate): suspension of the marketing authorisation due to risk of skin malignancy PDF, 116KB, File does not meet accessibility standards Date: 27. January 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ingenol mebutate

LEO Pharma would like to inform you about the suspension of the marketing authorisation of Picato (ingenol mebutate) as a precautionary measure due to growing concerns on the possible risk of skin malignancy.

Direct Healthcare Professional Communication (DHPC) on Implanon NXT® - Etonogestrel 68 mg for subcutaneous use: updated instructions for inserting and removing the implant PDF, 188KB, File is accessible Date: 15. January 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etonogestrel

In consultation with the Federal Institute for Drugs and Medical Devices (BfArM), MSD Sharp & Dohme GmbH informs that the instructions for inserting and removing the implant have been updated to further minimize the risk of neurovascular …