BfArM - Federal Institute for Drugs and Medical Devices

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Dear Doctor Letter (Rote-Hand-Brief) on Victrelis (boceprevir): Drug interactions with ritonavir-boosted HIV protease inhibitors PDF, 100KB, File is accessible Date: 24. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: boceprevir

In co-ordination with the European Medicines Agency (EMA) the pharmaceutical entrepreneur is circulating information on new findings on drug interactions between boceprevir, a recently licensed oral inhibitor of the hepatitis C virus …

Rote-Hand-Brief on Victrelis® PDF, 100KB, File is accessible Date: 24. February 2012 Topics: Pharmakovigilanz Type: Download

Active substance: boceprevir

Final SmPC and PL wording agreed by the PhVWP December 2011 PDF, 44KB, File is accessible Date: 14. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording agreed by the PhVWP December 2011

Ukrain: New findings with regard to detrimental effects of the medicinal product Date: 09. February 2012 Topics: Pharmakovigilanz Type: Risk information

Active substance:

In the course of recent findings, the BfArM has extended its assessment of the medicinal product Ukrain and now classifies Ukrain as an unsafe medicinal product.

Final SmPC and PL wording agreed by the PhVWP in September 2011 PDF, 59KB, File is accessible Date: 03. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording agreed by the PhVWP in September 2011

Final SmPC and PL wording Agreed by PhVWP in June 2011 PDF, 487KB, File is accessible Date: 03. February 2012 Topics: Pharmakovigilanz Type: Download

Final SmPC and PL wording Agreed by PhVWP in June 2011

Information Letter on Mircera® PDF, 886KB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Download

Active substance: methoxy-polyethylenglycol-epoetin beta

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Impending supply failure, note on switching to alternative treatments PDF, 1MB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Information Letter on Mircera® (methoxy polyethylene glycol-epoetin beta): Possible shortages: Note on switching to alternative treatments PDF, 886KB, File is accessible Date: 02. February 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: methoxy polyethylene glycol-epoetin beta

An information letter with treatment recommendations has been circulated to treating physicians and pharmacies concerned.

Dear Doctor Letter (Rote-Hand-Brief) on Gilenya® (fingolimod): Increased cardiovascular monitoring at the beginning of treatment PDF, 638KB, File is accessible Date: 27. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fingolimod

Important additional recommendations regarding a more intense monitoring of cardiovascular functions at the beginning of treatment with Gilenya® (fingolimod) in patients with relapsing-remitting multiple sclerosis.