BfArM - Federal Institute for Drugs and Medical Devices

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Information Letter on Protopic®: Recommendation to monitor maintenance therapy PDF, 304KB, File is accessible Date: 08. February 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tacrolimus

Important information on the safety of Protopic® Salbe (containing 0.03% or 0.1% tacrolimus) and recommendation to monitor maintenance therapy

Information Letter on Keppra®: Changed dose recommendations PDF, 1MB, File is accessible Date: 01. February 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: levetiracetam

Changed dose recommendations for use in children and adults are valid.

Sibutramin-containing medicines: Suspension of marketing authorisation because of increased risk for cardiovascular events PDF, 329KB, File is accessible Date: 25. January 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sibutramin

The BfArM wishes to inform the public that the suspension of marketing authorisation for sibutramin-containing medicines is considered necessary by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA).

Rote-Hand-Brief (Dear Doctor Letter) on Fluorescein Alcon® 10 %: Batch Recall Date: 15. December 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluorescein-sodium

Alcon Pharma GmbH recalls batches 160621F to 165639F in Germany. A Rote-Hand-Brief with attachment will be circulated.

Rote-Hand-Brief (Dear Doctor Letter) on Fluorescein Alcon® 10 % PDF, 1MB, File is accessible Date: 02. November 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fluorescein sodium

For immediate attention: The BfArM advises the strict observance of the warnings and precautions in the information for medical professionals. A Rote-Hand-Brief with attachment will be circulated.

Rote-Hand-Brief (Dear Doctor Letter) on INTELENCE® PDF, 143KB, File is accessible Date: 19. October 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: etravirin

For immediate attention: The BfArM advises the strict observance of the warnings and precautions in the information for medical professionals. A Rote-Hand-Brief informing about the changes will be circulated.

Information Letter on Tasigna® PDF, 770KB, File does not meet accessibility standards Date: 15. September 2009 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nilotinib

The Federal Institute for Drugs and Medical Devices (BfArM) requests consideration of the Information letter concerning the medicinal product Tasigna®