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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 …

Rote-Hand-Brief on Cardioxane® PDF, 279KB, File is accessible Date: 18. July 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dexrazoxane

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.

Rote-Hand-Brief on actos®, Competact® and Tandemact® PDF, 178KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Download

Active substance: pioglitazon

Information Letter on Regranex® PDF, 336KB, File is accessible Date: 10. June 2011 Topics: Pharmakovigilanz Type: Download

Active substance: becaplermin

Oral contraceptives containing drospirenone (e.g. Yasmin®) - Update of product information regarding the risk of venous thromboembolisms Date: 30. May 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: drospirenone

Epidemiological studies have shown that the risk of venous thromboembolic events (VTE) due to the use of combined oral contraceptives (COCs) containing drospirenone is greater than when taking COCs containing levonorgestrel (so-called second …

Oral administration of medicinal products containing buflomedil: EMA recommends suspension of marketing authorisation Date: 26. May 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: buflomedil

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended suspending the marketing authorisation for oral use of medicines containing buflomedil in EU Member States.

Information Letter on Anemet® 200 mg Tabletten PDF, 143KB, File is accessible Date: 26. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: dolasetrone

Information letter regarding Anemet® 200 mg tablets (dolasetron): Discontinuation of production PDF, 143KB, File is accessible Date: 26. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dolasetron

Due to the risk of arrhythmias in connection with the administration of Anemet® 200 mg tablets to adults for prevention and treatment of nausea and vomiting associated with cytostatic chemotherapy, the pharmaceutical manufacturer has renounced …