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Dear Doctor Letter (Rote-Hand-Brief) on Neupogen® (filgrastim) and Neulasta® (pegfilgrastim): Risk of capillary leak syndrom PDF, 567KB, File is accessible Date: 26. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: filgrastim

The marketing authorisation holder Amgen GmbH is circulating information on an adverse effect, the capillary leak syndrome (CLS), associated with the treatment of patients with cancer and/or healthy donors with Neupogen® (filgrastim) or Neulasta®

Diane® 35 and generic drugs: risk of thromboembolic events Date: 23. August 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone acetate/ethinylestradiol

In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.

Information Letter on oral ketoconazole-containing medicinal products (Nizoral® tablets): Suspension of marketing authorisation due to serious liver damage
PDF, 75KB, File is accessible
Date: 22. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

After an EU-wide review of the risk of hepatotoxicity under ketoconazole for treatment of fungal infections, the EMA recommends the suspension of the marketing authorisation for Nizoral® tablets (oral ketoconazole-containing medicinal …

Zyvoxid® 2 mg/ml solution for injection (linezolid): Temporary shortage
PDF, 148KB, File is accessible
Date: 15. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied. This shortage is the result of manufacturing problems of one of the external …

Mucosolvan® Solution for injection (ambroxol hydrochloride)
PDF, 87KB, File is accessible
Date: 09. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ambroxol hydrochloride

Information on mixing with commercially available 5% glucose solution for infusion.

LInformation Letter on Roferon®-A (interferon alfa-2a)
PDF, 2MB, File is accessible
Date: 07. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon alfa-2a

The marketing authorisation holder Roche Pharma is circulating an information letter on a temporary shortage in the supply of Roferon®-A due to relocation of the production site.

Information Letter on PegIntron® (peginterferon alfa-2b)
PDF, 64KB, File is accessible
Date: 02. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peginterferon alfa-2b

Information on the correct use of the new pre-filled injection pen.

Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib) PDF, 3MB, File is accessible Date: 31. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vismodegib

Important information for safe use, including information on contraceptive programmes.

Information Letter on VOTRIENT® (pazopanib)
PDF, 169KB, File is accessible
Date: 30. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pazopanib

Important change to frequency of serum liver test monitoring for hepatotoxicity.

DepoCyte® 50 mg injectable suspension (liposomal cytarabine for intrathecal injection): Back on the market as of 1 August 2013
PDF, 175KB, File is accessible
Date: 25. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

As of 1 August 2013, DepoCyte® will be available again regularly on the German market.