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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.

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.

Dear Doctor Letter (Rote-Hand-Brief) on Sprycel® (dasatinib): Potential risk of pulmonary arterial hypertension PDF, 363KB, File is accessible Date: 03. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dasatinib

The pharmaceutical entrepreneur is sending out a Dear Doctor Letter giving information on the potential risk of pre-capillary, pulmonary arterial hypertension (PAH) under treatment with Sprycel® (dasatinib).

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing pioglitazone (Actos®, Competact®, Tandemact®): New contraindications and warnings due to a slightly increased risk of bladder cancer PDF, 155KB, File is accessible Date: 01. August 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pioglitazone

The pharmaceutical entrepreneur is sending out a Dear Doctor Letter on Actos®, Competact® and Tandemact® giving information on new contraindications and warnings due to a slightly increased risk of bladder cancer.

Dear Doctor Letter (Rote-Hand-Brief) on Vimpat® (lacosamide) 15 mg/ml syrup: Recall due to a quality defect PDF, 46KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lacosamide

As of 15 September 2011, the pharmaceutical entrepreneur is recalling the medicinal product Vimpat® 15 mg/ml syrup from the market due to a quality defect. Other pharmaceutical forms are not affected.

Dear Doctor Letter (Rote-Hand-Brief) on Multaq® (dronedarone): New study results on increased cardiovascular risks PDF, 321KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dronedarone

New data from a prematurely discontinued study (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients with permanent atrial fibrillation due to treatment with dronedarone.

Dear Doctor Letter (Rote-Hand-Brief) on Cardioxane® (dexrazoxane): Restricted indications PDF, 279KB, File is accessible Date: 18. July 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dexrazoxane

As part of an arbitration by the EMA in 2017, the contraindications for children and adolescents listed in this dear Doctor Letter were partially removed.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing pioglitazone (actos®, Competact®, Tandemact®): Increased incidence of bladder cancer PDF, 178KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pioglitazone

Important safety information on the use of medicinal products containing pioglitazone.

Information Letter regarding Regranex® Gel (becaplermin): Discontinuation of distribution in Europe PDF, 336KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: becaplermin

According to information from the pharmaceutical manufacturer, the distribution of Regranex® Gel (becaplermin 0.01%) in Europe will be discontinued as of 30 June.