BfArM - Federal Institute for Drugs and Medical Devices

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258 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.

Oxbryta (voxelotor): EMA confirms suspension of sickle cell disease medicine Oxbryta Date: 23. October 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: voxelotor

EMA confirms suspension of sickle cell disease medicine Oxbryta

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.

Information for marketing authorisation holders: Current information on submission for step 3 Date: 23. July 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 3

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).

German SAE Report Form PDF, 1MB, File does not meet accessibility standards Date: 28. May 2025 Topics: Medical devices Type: Form

Report form for reporting of serious adverse events (SAE) in clinical trials or performance studies for use by sponsors according to § 3 (5) of the Ordinance on Medical Devices Vigilance

PDF-Form (use of Adobe Acrobat 9.X recommended)

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.

Ocaliva: Review of the risk-benefit ratio Date: 09. December 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

On 26 November 2024, the General Court dismissed the action for interim measures, which means that the revocation decision for Ocaliva has now taken effect.

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 …

Pseudoephedrine: Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Date: 04. April 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: pseudoephedrine

With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.

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.

Contrast agents containing gadolinium: Deposits in the brain and other tissues Date: 16. February 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gadolinium

For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.

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.