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Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): Restrictions regarding the use of Multaq® PDF, 439KB, File is accessible Date: 30. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has decided on restrictions as well as additional contraindications and warnings regarding the use of Multaq®.

Rote-Hand-Brief on Apidra® PDF, 81KB, File is accessible Date: 26. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: insulin glulisine

Additional information (available in German only):

Dear Doctor Letter (Rote-Hand-Brief) on Apidra® cartridges (insulin glulisine [produced by recombinant DNA technology]): Shortage of Apidra®

PDF, 81KB, File is accessible
Date: 26. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: insulin glulisine

Information on a temporary shortage in the supply of Apidra 3 ml cartridges. In Germany, this concerns the following products: Apidra® cartridge, Apidra® cartridge for OptiClik®, Apidra® SoloStar®, Apidra® OptiSet®.

Rote-Hand-Brief on Nplate® PDF, 427KB, File is accessible Date: 16. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: romiplostim

Dear Doctor Letter (Rote-Hand-Brief) on Nplate® (romiplostim): Risk of disease progression of pre-existing myelodysplastic syndrome (MDS) to acute myeloid leukemia (AML) PDF, 427KB, File is accessible Date: 16. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: romiplostim

Important safety-relevant information on the risk of disease progression to an acute myeloid leukemia with romiplostin (Nplate®) use in patients with myelodysplastic syndrome (MDS).

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Supply failure PDF, 114KB, File is accessible Date: 06. September 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

From the middle of September a temporary supply failure of Caelyx® (pegylated liposomal doxorubicin) is likely to ocur resulting in a further decline in patient supply.

Rote-Hand-Brief on Caelyx® PDF, 114KB, File is accessible Date: 06. September 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

Dear Doctor Letter (Rote-Hand-Brief) on Caelyx® (pegylated liposomal doxorubicin): Likely shortage PDF, 116KB, File is accessible Date: 08. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Likely global shortage of Caelyx® (pegylated liposomal doxorubicin) possibly resulting in supply problems for patients in Germany.

Rote-Hand-Brief on Caelyx® PDF, 116KB, File is accessible Date: 05. August 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pegylated liposomal doxorubicin

Rote-Hand-Brief on Sprycel® PDF, 363KB, File is accessible Date: 03. August 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dasatinib