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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.

Rote-Hand-Brief on Actos®, Competact® und Tandemact® PDF, 155KB, File is accessible Date: 01. August 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pioglitazone

Changes in Summary of Product Characteristics and Package Leaflet

Rote-Hand-Brief on Vimpat® PDF, 46KB, File is accessible Date: 29. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: lacosamide

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.

Champix®: The European Medicines Agency confirms a positive benefit-risk balance Date: 28. July 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: varenicline

The benefits of Champix® as a smoking-cessation medicine outweigh the reported slight increase in cardiovascular events. The European Medicines Agency has confirmed that the benefit-risk balance for Champix® (varenicline) remains positive, …

Rote-Hand-Brief on Multaq® PDF, 321KB, File is accessible Date: 27. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dronedarone

Pioglitazone: The European Medicines Agency recommends new contraindications and warnings for medicinal products containing pioglitazone due to a slightly increased risk of bladder cancer Date: 22. July 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: pioglitazone

In its July meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency finalised the benefit-risk assessment for medicinal products containing pioglitazone. This confirms a slightly increased occurrence of …

Dronedarone: EMA renews information on the benefit-risk assessment of Multaq®
Date: 22. July 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: dronedarone

The European Medicines Agency is currently reviewing the benefit-risk balance of the antiarrhythmic agent dronedarone (Multaq®). New study data (PALLAS study) indicate a significantly increased risk of cardiovascular adverse events in patients …