BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Rote-Hand-Brief on Gilenya® PDF, 638KB, File is accessible Date: 26. January 2012 Topics: Pharmakovigilanz Type: Download

Active substance: fingolimod

Dear Doctor Letter (Rote-Hand-Brief) on Velcade® (bortezomib): Intravenous injection is the only correct route of administration PDF, 127KB, File is accessible Date: 16. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The only licensed route of administration of Velcade® (1 mg, 3.5 mg, powder for solution for injection) is via intravenous injection. Velcade® must not be administered in any other manner.

Rote-Hand-Brief on Velcade® 1 mg, 3.5 mg, powder for solution for injection PDF, 127KB, File is accessible Date: 13. January 2012 Topics: Pharmakovigilanz Type: Download

Active substance: bortezomib

Citalopram and risk of QT prolongation - Final SmPC and PL wording agreed by the PhVWP in October 2011 PDF, 48KB, File is accessible Date: 10. January 2012 Topics: Pharmakovigilanz Type: Download

Citalopram - SmPC und PL Texte

Rote-Hand-Brief on Rasilez®, Rasilez HCT® and Rasilamlo® PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Download

Active substance: aliskiren

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): Potential risks of cardiovascular or renal adverse events PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on potential risks of cardiovascular or renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular diseases who are being treated with medicinal products containing aliskiren.

Rote-Hand-Brief on Hexvix® PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: hexaminolevulinate hydrochloride

Dear Doctor Letter (Rote-Hand-Brief) on UVADEX™: Visual inspection of vials prior to administration PDF, 57KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Therakos Europe advises healthcare professionals to visually inspect the UVADEX™ vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the …

Dear Doctor Letter (Rote-Hand-Brief) on Hexvix®: Visual inspection of vials prior to administration PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hexaminolevulinate hydrochloride

Ipsen Pharma GmbH advises healthcare professionals to visually inspect the Hexvix® vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of …

Rote-Hand-Brief on UVADEX PDF, 57KB, File is accessible Date: 27. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: methoxsalen

Rote-Hand-Brief on Virazole® PDF, 104KB, File is accessible Date: 23. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: ribavirin

Dear Doctor Letter (Rote-Hand-Brief) on Virazole® (ribavirin) 6 g dry substance, powder to be reconstituted for aerosol administration: Problems with sterility and particle contamination at the manufacturing site PDF, 104KB, File is accessible Date: 23. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ribavirin

MEDA Pharma recommends only treating patients with Virazole® if its use is considered to be absolutely essential.

BfArM issues warning against use of Ukrain Date: 22. December 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance:

According to information available to the BfArM, large amounts of the medicinal product "Ukrain" are still being marketed illegally in Germany and other EU Member States.

Medicinal products containing somatropin: EMA confirms positive benefit/risk balance. Prescribers are reminded to adhere strictly to authorised indications and dosage recommendations Date: 19. December 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: somatropin

In the course of the risk assessment procedure for medicinal products containing somatropin, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a recommendation confirming that the …

Rote-Hand-Brief on Strattera® PDF, 286KB, File is accessible Date: 13. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: atomoxetine

Additional information (available in German only):

Dear Doctor Letter (Rote-Hand-Brief) on Strattera® (atomoxetine): Risk of increased blood pressure and/or heart rate PDF, 286KB, File is accessible Date: 13. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: atomoxetine

Important safety-relevant information on the risk of increased blood pressure and/or heart rate associated with the use of Strattera® (atomoxetine) for treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

Rote-Hand-Brief on Ceplene® PDF, 71KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

active substance: histamine dihydrochloride

Rote-Hand-Brief on Torisel® PDF, 576KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

Active substance: temsirolimus

Final SmPC and PL wording agreed by PhVWP in September 2011 PDF, 14KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Download

Von der Pharmakovigilance Working Party verabschiedete Texte der Fach- und Gebrauchsinformation

Dear Doctor Letter (Rote-Hand-Brief) on Torisel® (temsirolimus, concentrate and diluent for solution for infusion): Contamination of the diluent PDF, 576KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: temsirolimus

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the diluent prior to administration of Torisel® in order to exclude particle contamination. …