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: crisantaspase
The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that, due to a temporary shortage, Erwinase® 10.000 I.U./vial powder for solution for injection is currently only available under consideration of the provisions of Section 73 (3) AMG.
Active substance: Crisantaspase
The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that over a period of 4 to 5 weeks there will be temporary shortages as regards new orders of Erwinase®.
Active substance: etoposide
The company Bristol-Myers Squibb GmbH & Co. KGaA is circulating information regarding the shortage of Etopophos® 100-/1000 mg.
Active substance: rivastigmine
In association with the rivastigmine transdermal patches, Exelon® and Prometax®, cases of overdosage due to medication errors and incorrect administration have been reported.
Active substance: insulin aspart
The company Novo Nordisk Pharma GmbH is circulating information on the fact that a new colour scheme will be introduced for Fiasp® products as of July 2018 in order to improve their discernibility from Tresiba®.
Active substance: flupirtine
Following the European benefit-risk assessment, marketing authorisations of medicinal products containing the active substance flupirtine are revoked on an EU-wide level due to the risk of liver damage.
Active substance: eribulin
Danger of dosing errors due to the fact that the dose is stated differently in the EU compared to several other regions and in some publications.
Active substance: haloperidol
Due to questions regarding the recently circulated Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing haloperidol, the company Janssen-Cilag GmbH (Haldol®-Janssen) would like to clarify the aspects raised most frequently.
Active substance: mecasermin, recombinant human IGF-1
The company Ipsen Pharma GmbH is sending out information that the supply with Increlex® (mecasermin) is no longer interrupted.
Active substance: mecasermin, recombinant human IGF-1
The company Ipsen Pharma GmbH is sending out information that as of immediately the medicinal product Increlex® 10 mg/ml solution for injection can no longer be supplied in Germany.
