BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Search i

Search help

  • Enter one or more search terms in the search field. Upper and lower case are not relevant.
  • As soon as you have entered three letters in the search field, various search words will be suggested from which you can choose one.
  • If you are searching for a certain group of words, put these words in double quotes. The hits will then contain the words in the order you entered, e.g. "medicines for children".
  • Multiple search terms can also be combined with the Boolean operators AND and OR. When using the operator AND, the results contain the intersection of all search terms. When using the operator OR, the hits contain one of the search terms or only individual search terms. The result set is therefore significantly larger. Please note that these operators must be written in capital letters.
  • If you receive a (too) large number of hits as a result of your search, you can narrow it down by using filters. These filter options appear to the left of the search results and are subdivided into:

    • category (e.g. safety of medicinal products, medical devices, code systems)
    • format (e.g. download, risk information, DHPCs)
    • time interval (e.g. last 30 days, older than ...)
  • Selected filters can be removed individually or all at once ("Show all results").
  • By default, search results are sorted by relevance, but they can also be sorted chronologically ("Latest entries first" or "Oldest entries first").

Enter search term

499 results

Results per page: 10 20 30

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.

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.

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.

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 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.

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)

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.

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.

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.

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.

Direct Healthcare Professional Communication (DHPC) on glatiramer acetate: Anaphylactic reactions may occur months up to years after treatment initiation PDF, 360KB, File is accessible Date: 19. August 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: glatiramer acetate

The marketing authorisation holders of glatiramer acetate-containing medicinal products provide information about anaphylactic reactions that can occur shortly after the administration of glatiramer acetate, even months to years after the start of …

Update of Direct Healthcare Professional Communication (DHPC) on Peritrast 180/31%, Peritrast Infusio 31 % (retro) and Peritrast 300/60% solutions for injection: Risk due to visible particles PDF, 144KB, File does not meet accessibility standards Date: 16. August 2024 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: amidotrizoic acid

The company Dr. Franz Köhler Chemie GmbH informs that during the ongoing stability program visible particles have been found in the medicinal products Peritrast 180/31%, Peritrast Infusio 31% (retro) and Peritrast 300/60%.