BfArM - Federal Institute for Drugs and Medical Devices
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If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
DHPCs (Rote-Hand-Briefe) and Information Letters
Here you will find Direct Healthcare Professional Communications - DHPCs (so-called "Rote-Hand-Briefe") and Information Letters sent out by pharmaceutical companies informing healthcare professionals about newly identified major drug-associated risks and measures to reduce them. The files are available in German only. The information published here only applies to drugs which are in the BfArM's responsibility.
"Rote-Hand-Briefe" and further safety information for vaccines and biomedical medicinal products published by the Paul-Ehrlich-Institute can be found at: Rote-Hand-Briefe (PEI).
After clicking on the "search all DHPCs and Information letters" button, the total amount of all DHPCs and Information letters can be searched in the website search.
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.
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.
Active substance: clozapine
The marketing authorisation holders of clozapine-containing medicinal products provide information on the revised recommendations for routine blood count monitoring.
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.
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.
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.
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.
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.
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.
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.
