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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.

Dear Doctor Letter (Rote-Hand-Brief) on Velcade® (bortezomib): Intravenous injection is the only correct route of administration PDF, 127KB, File is accessible Date: 16. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bortezomib

The only licensed route of administration of Velcade® (1 mg, 3.5 mg, powder for solution for injection) is via intravenous injection. Velcade® must not be administered in any other manner.

Dear Doctor Letter (Rote-Hand-Brief) on Rasilez®, Rasilez HCT® and Rasilamlo® (aliskiren): Potential risks of cardiovascular or renal adverse events PDF, 72KB, File is accessible Date: 05. January 2012 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aliskiren

Important information on potential risks of cardiovascular or renal adverse events in patients with type 2 diabetes and renal impairment and/or cardiovascular diseases who are being treated with medicinal products containing aliskiren.

Dear Doctor Letter (Rote-Hand-Brief) on UVADEX™: Visual inspection of vials prior to administration PDF, 57KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance:

Therakos Europe advises healthcare professionals to visually inspect the UVADEX™ vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of the …

Dear Doctor Letter (Rote-Hand-Brief) on Hexvix®: Visual inspection of vials prior to administration PDF, 668KB, File is accessible Date: 29. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hexaminolevulinate hydrochloride

Ipsen Pharma GmbH advises healthcare professionals to visually inspect the Hexvix® vials prior to administration in order to exclude particle contamination. Furthermore, suspected cases of sepsis should be reported along with the numbers of …

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.

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).

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. …

Dear Doctor Letter (Rote-Hand-Brief) on Ceplene® (0.5 mg/0.5 ml solution for injection): Contamination of the diluent PDF, 71KB, File is accessible Date: 09. December 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: histamine dihydrochloride

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advises healthcare professionals to visually inspect the vial prior to administration of Ceplene® in order to exclude particle contamination. The …