BfArM - Federal Institute for Drugs and Medical Devices

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121 results

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Promethazine: New contraindication for children under 6 years of age Date: 20. November 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: promethazine

The BfArM informs that the use of medicines containing promethazine is contraindicated in children under the age of 6 due to age-specific risks.

Finasteride- and dutasteride-containing medicines: Suicidal thoughts and behaviours Date: 16. September 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: finasteride, dutasteride

The Federal Institute for Drugs and Medical Devices (BfArM) implements the final decision of the EU Commission nationally.

Azithromycin: Re-evaluation of the benefits and risks Date: 12. September 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: azithromycin

The European Commission's final decision on the risk assessment procedure for azithromycin has been published.

Levamisole: Review of the risk of leukoencephalopathy Date: 05. September 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: levamisole

The European Medicines Agency (EMA) is initiating a safety review of medicines containing levamisole for the treatment of parasitic worm infections.

Direct Healthcare Professional Communication (DHPC) on Amversio 1 g powder for oral administration: Wrong PZN encoded in the 2D barcode PDF, 178KB, File does not meet accessibility standards Date: 22. August 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: betaine

SERB Pharmaceuticals has reported that three batches were packaged for the German market with a faulty PZN number in the NTIN-DE and in the 2D barcode.

Thalidomide, lenalidomide and pomalidomide: Requirements for the prescription in Germany Date: 06. August 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: thalidomide, lenalidomide, pomalidomide

The Federal Institute for Drugs and Medical Devices (BfArM) once again draws attention to the applicable safety regulations and the requirements for the proper prescription of thalidomide, lenalidomide and pomalidomide.

Angusta (misoprostol for induction of labour): Reports of overdose and contraindicated use with labour already in progress Date: 27. June 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: misoprostol

Reminder of the authorisation-compliant application.

Sodium oxybate: Review of use in alcohol dependence Date: 23. June 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: sodium oxybate

The European Medicines Agency (EMA) is starting to review medicines containing sodium oxybate.

Mysimba: Potential long-term cardiovascular risk Date: 03. June 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: naltrexone, bupropion

EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation).

Ipidacrine: Review of efficacy in the authorised indications Date: 23. May 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: ipidacrin

The European Medicines Agency (EMA) is starting to review medicines containing ipidacrine.

Information letter on Toxogonin (obidoxime chloride) 250 mg/ml solution for injection: Change of storage conditions PDF, 132KB, File does not meet accessibility standards Date: 20. May 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: obidoxime chloride

The company SERB SA and the German co-distributor Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG inform about a change in the storage conditions of Toxogonin.

Metamizole-containing medicinal products: Risk of agranulocytosis - referral Date: 21. March 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: metamizole

With the publication of the European Commission's decision, the risk assessment procedure on the medicinal products containing metamizole has been completed.

Information letter on Kisqali 200 mg film tablets: Change to storage conditions and shelf life PDF, 164KB, File does not meet accessibility standards Date: 17. February 2025 Topics: Pharmakovigilanz Type: Risk information

Active substance: ribociclib

The company Novartis Pharma GmbH informs about a change to storage condtions and shelf life of Kisqali 200 mg film tablets.

Information letter on Airbufo Forspiro 160 µg/4,5 mg and 320 µg/9 mg: Possible failure of dose delivery from the first use PDF, 151KB, File does not meet accessibility standards Date: 22. November 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: budesonide and formoterole

The company Sandoz GmbH informs about a possible failure of dose delivery in several batches of Airbufo Forspiro.

Information letter on Vitamin B12-ratiopharm N solution for injection: Recall due to visible particles PDF, 242KB, File does not meet accessibility standards Date: 03. September 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: vitamine B12

The company ratiopharm GmbH informs about a precautionary recall of all batches on the market due to visible particles

Mysimba (naltrexone/bupropion): EMA advises about risks of using weight loss medicine Mysimba with opioids Date: 29. July 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: naltrexon, bupropion

The European Medicines Agency (EMA) draws attention to the risks of using the weight loss medication Mysimba in combination with opioids.

Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India Date: 15. July 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: various

The Federal Institute for Drugs and Medical Devices (BfArM) implements the decision of the European Commission of 24 May 2024 for the German marketing authorisations with its decision of 17 June 2024.

Medicinal products containing hydroxyprogesterone: Safety review Date: 02. July 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: hydroxyprogesterone

Hydroxyprogesterone caproate medicines to be suspended from the EU market.

Update of Direct Healthcare Professional Communication (DHPC) on Oncofolic 50 mg/ml solution for infusion/injection, strength 100 mg, 400 mg, 500 mg and 900 mg: Possible risk of visible particles in the solution, use of a filter PDF, 296KB, File does not meet accessibility standards Date: 27. May 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: disodium folinate

The company medac GmbH informs that during the ongoing stability program visible particles have been found in the medicinal product Oncofolic 50 mg/ml solution for injection/infusion.

Information letter on Carmubris powder and solvent for solution for infusion: Incorrect labeling PDF, 443KB, File does not meet accessibility standards Date: 23. May 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: carmustine

The company TILLOMED PHARMA GmbH informs about an incorrect labeling of three batches of the medicinal product Carmubris powder and solvent for solution for infusion

Information Letter on Aptivus 250 mg soft capsules: Missing or barely readable capsule imprint PDF, 112KB, File does not meet accessibility standards Date: 19. April 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: tipranavir

The company Boehringer Ingelheim Pharma GmbH & Co. KG informs that batch 308715 of the medicinal product Aptivus 250 mg soft capsules (120 capsules per bottle) may contain capsules with only a faint imprint “TPV 250” or without this imprint at …

Information Letter on Spiolto Respimat: Possibly defective dose indicator PDF, 105KB, File does not meet accessibility standards Date: 01. March 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: tiotropium bromide, olodaterol hydrochloride

The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in two batches of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms.

Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Date: 26. January 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines.

Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends precautionary measures for the treatment of male patients with valproate-containing medicinal products.

Topiramate-containing medicinal products: Risks associated with the use of topiramate during pregnancy and in women of childbearing age. Date: 01. December 2023 Type: Risk information

Active substance: topiramate

In a decision dated 22 November 2023, the Federal Institute for Drugs and Medical Devices (BfArM) implements the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures - Human (CMDh) of 11 October …

Valproate: Evaluation of data on paternal exposure by the PRAC Date: 16. August 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: valproate

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children born to men taking valproate-containing medicines.

Methotrexate-containing medicinal products: Improving risk awareness by changing risk-minimising measures - results of a study commissioned by the EMA Date: 30. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: methotrexate

The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures …

Information Letter on Mitem 20 mg of the company Substipharm: Withdrawal of the restriction for intravenous administration PDF, 86KB, File does not meet accessibility standards Date: 22. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: mitomycin

Substipharm informs that the mitomycin-containing medicinal product Mitem® 20 mg - powder for the preparation of a solution for injection or infusion or powder and solvent for the preparation of a solution can be used again for intravenous …

Pholcodine: Risk of anaphylactic reactions Date: 14. March 2023 Topics: Pharmakovigilanz Type: Risk information

Active substance: pholcodine

The European Commission made its final legally binding decision on March 06, 2023, resulting in the revocation of national authorizations. This decision, addressed to the EU member states, is valid in all EU member states. This concludes the European …

Azido impurity in losartan Date: 12. July 2022 Topics: Pharmakovigilanz Type: Risk information

Active substance: losartan

Azido impurity in losartan