BfArM - Federal Institute for Drugs and Medical Devices

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819 results

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Dear Doctor Letter on Xyrem®: Risk of dosing errors PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: sodium oxybate

Risk of dosing errors with Xyrem® (sodium oxybate) because gramme (g) and milliliter (ml) are easily confused.

Rote-Hand-Brief on Xyrem® PDF, 1MB, File is accessible Date: 12. August 2010 Topics: Pharmakovigilanz Type: Download

Active substance: sodium oxybate

Dear Doctor Letter (Rote-Hand-Brief) regarding Ketoprofen, topical formulations PDF, 58KB, File is accessible Date: 09. August 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoprofen

Important safety information about the risk of photosensivity reactions in association with topical uses of Ketoprofen.

Rote-Hand-Brief on Ketoprofen
PDF, 58KB, File is accessible
Date: 05. August 2010 Topics: Pharmakovigilanz Type: Download

Active substance: ketoprofene

Rote-Hand-Brief on Cardioxane® PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: dexrazoxane

Dear Doctor letter (Rote Hand Brief) on Cardioxane®: Secondary neoplasia in children PDF, 1MB, File is accessible Date: 26. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

Important safety information on Cardioxane® (dexrazoxane) and increased risk for secondary neoplasia in children.

Rosiglitazone: The BfArM and the EMA emphasise restrictions in indications Date: 23. July 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: rosiglitazone

In July 2010 the CHMP at the EMA initiated assessment of new study results on the antidiabetic, rosiglitazone. The BfArM, like the CHMP, is repeating the advice that the long-existing restrictions in rosiglitazone indications should be …

Rosiglitazone: The EMA initiates assessment of new study results Date: 16. July 2010 Topics: Pharmakovigilanz Type: Risk information

Active substance: rosiglitazone

In July 2010 the CHMP at the EMA is assessing the recently published new study results on rosiglitazone (June 2010).

Rote-Hand-Brief on Invirase® PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Download

Active substance: saquinavir

Dear Doctor letter on Invirase®: QT-prolongations PDF, 2MB, File is accessible Date: 15. July 2010 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: saquinavir

Additional safety information on the arrhythmogenic risk due to QT and PR interval prolongations in association with Invirase (saquinavir).