BfArM - Federal Institute for Drugs and Medical Devices

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Direct Healthcare Professional Communication (DHPC) on Tecfidera® (dimethyl fumarate): updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia PDF, 90KB, File is accessible Date: 09. November 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

Biogen Netherlands B.V. informs that cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with Tecfidera with existing mild lymphopenia (lymphocyte value ≥ 0.8 x 109/l and below the lower standard …

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.

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.

Direct Healthcare Professional Communication (DHPC) on leuprorelin-containing depot drugs: need to strictly follow the instructions regarding preparation and administration to reduce the risk of application errors PDF, 85KB, File is accessible Date: 30. July 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin

The marketing authorisation holders of depot medicines containing leuprorelin would like to inform about application errors which could possibly lead to a reduced efficacy.

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: pre-treatment testing to identify DPD-deficient patients PDF, 109KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-fluorouracil, capecitabine, tegafur

The marketing authorisation holders of medicines containing 5-fluorouracil i.v. (5-FU), capecitabine or tegafur, would like to inform you that patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at an …

Direct Healthcare Professional Communication (DHPC) on flucytosine: updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency PDF, 97KB, File is accessible Date: 04. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: Flucytosine

Mylan (Meda Pharma GmbH & Co KG) would like to inform you that the treatment with flucytosine is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) deficiency due to the risk of life-threatening toxicity.

Direct Healthcare Professional Communication (DHPC) on tolperisone: a reminder of the negative risk-benefit balance if the use is outside the authorised indication PDF, 952KB, File is accessible Date: 02. June 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The marketing authorisation holders of tolperisone containing drugs are once again informing, that since 2013 tolperisone is only authorised for the symptomatic treatment of spasticity after a stroke in adult patients.

Information Letter on Anticholium® (physostigmine salicylate): change in the approval PDF, 158KB, File is accessible Date: 14. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: physostigmine salicylate

Dr. Franz Köhler Chemie GmbH informs about the change in the approval of Anticholium®. The intramuscular application is no longer approved. Anticholium® is now sodium metabisulfite free.

Direct Healthcare Professional Communication (DHPC) on brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine PDF, 572KB, File is accessible Date: 12. May 2020 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: brivudine

Marketing authorisation holders of medicines containing brivudine inform that deaths may occur as a result of interaction between brivudine and fluoropyrimidines.

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 …