BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Rote-Hand-Brief on Aclasta® PDF, 143KB, File does not meet accessibility standards Date: 12. March 2010 Topics: Pharmakovigilanz Type: Download

Active substance: zoledronic acid

Dear Doctor Letter (Rote-Hand-Brief) on Aclasta®: Reports on renal dysfunction and renal failure PDF, 143KB, File is accessible Date: 12. March 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: zoledronic acid

Additional safety information on reports on renal dysfunction and renal failure with Aclasta®.

Reporting form for adverse drug reactions (ADR) PDF, 363KB, File does not meet accessibility standards Date: 23. February 2010 Topics: Pharmakovigilanz Type: Form

If you have observed an adverse drug reaction that you wish to report, please use the form provided here in the table. ADR s can also be reported online. Since the scientific assessment of reported events requires specialised medical information, the

Circular Letter about Protopic® PDF, 304KB, File does not meet accessibility standards Date: 08. February 2010 Topics: Pharmakovigilanz Type: Download

Active substance: tacrolimus

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® PDF, 1MB, File does not meet accessibility standards Date: 01. February 2010 Topics: Pharmakovigilanz Type: Download

Active substance: levetiracetame

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.

Rote-Hand-Brief on Reductil® PDF, 716KB, File does not meet accessibility standards Date: 25. January 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sibutramine

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).

Sibutramin: New Study Data under Evaluation Date: 18. December 2009 Topics: Pharmakovigilanz Type: Risk information

Active substance: sibutramin

The Committee for Human Medicinal Products (CHMP) at the European Medicines Agency (EMA) is currently concerned with a risk evaluation of sibutramin. The re-evaluation was prompted by the preliminary results of a large long-time study …