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: 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.
Active substance: pseudoephedrine
Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicinal products.
Active substance: Inclisiran
The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.
Active substance: etoposide
The marketing authorization holders of medicinal products containing etoposide (not etoposide phosphate) inform that there is an increased risk of infusion-related hypersensitivity reactions when using inline filters.
