BfArM - Federal Institute for Drugs and Medical Devices

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585 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.

Direct Healthcare Professional Communication (DHPC) on Phenhydan solution for injection: risk of visual particles, use of a particle filter PDF, 185KB, File does not meet accessibility standards Date: 07. November 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: phenytoin sodium

The company Desitin Arzneimittel GmbH informs about a possible quality defect of the medicinal product Phenhydan solution for injection.

Direct Healthcare Professional Communication (DHPC) on caspofungin: Avoid use of polyacrylonitrile membranes during continuous renal replacement therapy. PDF, 147KB, File is accessible Date: 09. October 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: caspofungin

The marketing authorisation holders of caspofungin containing medicines would like to inform that during treatment with caspofungin the use of polyacrylonitrile membranes during continuous renal replacement therapy should be avoided.

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.

Direct Healthcare Professional Communication (DHPC) on finasteride und dutasteride: New measures to minimise the risk of suicidal thoughts PDF, 252KB, File does not meet accessibility standards Date: 15. September 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: finasteride, dutasteride

The marketing authorisation holders of finasteride- and dutasteride-containing medicinal products provide information on suicidal thoughts as an adverse drug reaction of orally administered finasteride-containing products.

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.

Direct Healthcare Professional Communication (DHPC) on Isozid 0.5 N powder for solution for infusion: Visual particles, use of a particle filter PDF, 230KB, File does not meet accessibility standards Date: 10. September 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: isoniazid

Esteve Pharmaceuticals GmbH has issued a warning about visible particles in batch 286490A of the medicinal product Isozid 0.5 N powder for solution for infusion after reconstitution.

Direct Healthcare Professional Communication (DHPC) on Clozapine: Revised recommendations for routine blood count monitoring with regard to the risk of agranulocytosis PDF, 188KB, File is accessible Date: 08. September 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: clozapine

The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.

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 Lipidem emulsion for infusion: Subvisual agglomerates, use of an infusion filter for lipid emulsions PDF, 161KB, File does not meet accessibility standards Date: 29. August 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: soya bean oil, refined, medium-chain triglycerides, omega-3-acid triglycerides

Braun Melsungen AG informs about agglomerates consisting of droplet-like structures that have been detected in individual batches of the medicinal product.

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.

Direct Healthcare Professional Communication (DHPC) on Evrysdi 0,75 mg/ml powder for oral solution: Omission of mandatory labelling statement PDF, 141KB, File does not meet accessibility standards Date: 21. August 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: risdiplam

The marketing authorization holder Roche Registration GmbH informs about the omission of a mandatory labelling statement on the bottle labels, product carton, summary of product characteristics and Instruction for
Constitution.

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.

Direct Healthcare Professional Communication on Opzelura 15 mg/g cream: Important information regarding presence of particles in Opzelura cream PDF, 154KB, File does not meet accessibility standards Date: 24. April 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ruxolitinib phosphate

The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.

Direct Healthcare Professional Communication (DHPC) on Livopan (nitrous oxide/oxygen) 50 %/50 % gas for medical use, compressed: Risk of gas leakage and interruption of gas supply to patients when the flow rate is above 8 l/min PDF, 167KB, File does not meet accessibility standards Date: 22. April 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nitrous oxide, oxygen

The company Linde Sverige AB informs about a quality defect of the medicinal product Livopan when used with a Fir Tree connector for direct connection with O2/N2O breathing systems.

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.

Direct Healthcare Professional Communication on Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion: Risk of cracked or broken vials PDF, 303KB, File is accessible Date: 27. February 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aztreonam, avibactam

The company Pfizer Europe MA EEIG informs about the risk of broken or cracked glass vials of  Emblaveo 1.5 g/0.5 g  powder for concentrate for solution for infusion.

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.

Direct Healthcare Professional Communication (DHPC) on Veoza (fezolinetant): Risk of drug-induced liver injury and new recommendations on monitoring of liver function before and during treatment PDF, 490KB, File is accessible Date: 13. January 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fezolinetant

The marketing authorisation holder of Veoza (fezolinetant) would like to inform about the risk of drug-induced liver injury.

Direct Healthcare Professional Communication (DHPC) on metamizole-containing medicines: Important measures to minimise the serious outcomes of known risk of agranulocytosis PDF, 234KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: metamizole

The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.

Direct Healthcare Professional Communication (DHPC) on Cyanokit 5 g powder for solution for infusion: Potential microbial contamination of certain batches PDF, 214KB, File does not meet accessibility standards Date: 09. December 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxycobalamin

The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.

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.

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.): In patients with moderate or severe renal impairment, uracil levels measured to determine dihydropyrimidine dehydrogenase (DPD) deficiency should be interpreted with caution. PDF, 338KB, File does not meet accessibility standards Date: 24. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: 5-fluorouracil

The marketing authorisation holders of 5-fluorouracil containing medicines would like to inform that in patients with moderate or severe renal impairment, blood uracil levels used for dihydropyrimidine dehydrogenase (DPD) phenotyping should be …

Direct Healthcare Professional Communication (DHPC) on medroxyprogesterone acetate: Risk of meningioma and measures to minimise this risk PDF, 405KB, File does not meet accessibility standards Date: 09. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: medroxyprogesterone acetate

The marketing authorisation holder of medroxyprogesterone acetate-containing medicines would like to inform you about the increased risk of developing meningioma with high doses of medroxyprogesterone acetate.

Direct Healthcare Professional Communication (DHPC) on Oxbryta (voxelotor): Suspension of EU marketing authorisation PDF, 454KB, File is accessible Date: 07. October 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: voxelotor

Pfizer Europe would like to inform you that the marketing authorisation for Oxbryta is suspended in the European Union as a precautionary measure while the review of the benefits and risks is ongoing.