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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.

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 …

Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Occurrence of thromboembolic events PDF, 129KB, File is accessible Date: 21. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

Important information on the occurrence of thromboembolic events associated with Thalidomide Celgene™ (thalidomide).

Information letter on Thyrogen® (thyrotropin alfa): Supply shortage due to a manufacturing issue and temporary treatment recommendations from the EMA PDF, 59KB, File is accessible Date: 11. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thyrotropin alfa

An information letter on the treatment recommendations has been sent to attending physicians and pharmacies concerned.

Information letter on Onsenal® (celecoxibe): Company-led drug withdrawal for the indication "familial adenomatous polyposis" (FAP) PDF, 2MB, File is accessible Date: 08. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: celecoxibe

Important information on the company-led drug withdrawal of Onsenal® (celecoxibe) for the indication familial adenomatous polyposis.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Potential risk of second primary tumours PDF, 389KB, File is accessible Date: 01. April 2011 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Important information on the potential risk of second primary tumours in patients treated with Revlimid® (lenalidomide).