BfArM - Federal Institute for Drugs and Medical Devices

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Rote-Hand-Brief on Thalidomide Celgene™ PDF, 129KB, File is accessible Date: 21. April 2011 Topics: Pharmakovigilanz Type: Download

Active Substance: thalidomide

(Extract from the Summary of Product Characteristics)

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® PDF, 59KB, File is accessible Date: 11. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: thyrotropin alfa

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® PDF, 2MB, File is accessible Date: 08. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: celecoxibe

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.

EMA announcement on possible radioactivity of medicinal products manufactured in Japan Date: 05. April 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance:

The BfArM calls attention to the public announcement made by the European Medicines Agency (EMA) in co-ordination with the European licensing authorities following the radiation leak from the Fukushima Daiichi nuclear power plant in Japan.

Rote-Hand-Brief on Revlimid® PDF, 389KB, File is accessible Date: 01. April 2011 Topics: Pharmakovigilanz Type: Download

Active substance: lenalidomide

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).

Topiramate: Data concerning the risk of malformations Date: 22. March 2011 Topics: Pharmakovigilanz Type: Risk information

Active substance: topiramate

Based on evaluations from pregnancy registries, the USA has now also revised the product informations of medicinal products containing topiramate and has included corresponding warnings already implemented in European marketing authorisations.