BfArM - Federal Institute for Drugs and Medical Devices

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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. …