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: 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.
Active substance: angiotensin II
The company Paion Deutschland GmbH informs that in several hospitals in the USA vials of the medicinal product Giapreza have been detected that are not filled with the required volume.
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
Active substance: sodium perchlorate
Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage a different dosage (number of drops per millilitre).
Active substance: acitretin, alitretinoin, isotretinoin
The marketing authorisation holders of acitretin-, alitretinoin- and isotretinoin-containing medicinal products remind you of the pregnancy prevention program for oral retinoids.
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 all.
Active substance: nirmatrelvir, ritonavir
Pfizer reminds of already known drug interactions of paxlovid with certain immunosuppressants, including tacrolimus, with potentially life-threatening and fatal consequences.
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.
Active substance: chlormadinone acetate, ethinyl estradiol
The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol provide information about a slightly increased risk of venous thromboembolism.
Active substance: valproate
The marketing authorisation holders of valproate-containing medicinal products would like to inform you about new measures regarding an increased risk of neurodevelopmental disorders in children born to men treated with valproate.
