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Dear Doctor Letter (Rote-Hand-Brief) on Thalidomide Celgene™ (thalidomide): Risk of second primary haematological malignancies PDF, 288KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: thalidomide

The pharmaceutical manufacturer is sending out information on the risk of second primary haematological malignancies in patients treated with thalidomide.

Dear Doctor Letter (Rote-Hand-Brief) on INCIVO® (telaprevir): Occurrence of serious skin reactions PDF, 351KB, File is accessible Date: 08. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: telaprevir

The pharmaceutical manufacturer is sending out information on the occurrence of serious skin reactions associated with treatment with INCIVO®.

Dear Doctor Letter (Rote-Hand-Brief) on Mimpara® (cinacalcet): Occurrence of severe hypocalcaemia resulting in death PDF, 338KB, File is accessible Date: 26. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cinacalcet

Important safety-relevant information regarding a fatal case with severe hypocalcaemia in a clinical study in children and adolescents.

Information Letter on NULOJIX® (belatacept): Increased occurrence of acute graft rejection PDF, 113KB, File is accessible Date: 26. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: belatacept

The pharmaceutical manufacturer is sending out information on the increased occurrence of acute graft rejection under treatment with NULOJIX® (belatacept) associated with rapid corticosteroid taper in patients at high immunologic risk for …

Dear Doctor Letter (Rote-Hand-Brief) on Fentanyl®-Janssen and Durogesic® SMAT (12, 25, 50, 75, 100 µg/h), transdermal patch (active substance: fentanyl): New warning Date: 11. March 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fentanyl

New warning regarding medicinal products (and generics) containing fentanyl and the possible occurrence of serotonin syndrome if used concomitantly with serotonergic medicines.

Information Letter on NeuroBloc® (botulinum toxin type B): Risks related to "off-label“ use PDF, 848KB, File is accessible Date: 25. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: botulinum toxin type B

Serious adverse events were observed in connection with NeuroBloc® if used outside the licensed indication ("off-label“).

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tolperisone: Risk of hypersensitivity reactions PDF, 155KB, File is accessible Date: 21. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tolperisone

The pharmaceutical manufacturers are sending out information on the restriction of the indication for medicinal products containing tolperisone and on the risk of hypersensitivity reactions.

Information letter on Optimark® products (gadolinium): New peel-off tracking label PDF, 73KB, File is accessible Date: 21. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: gadolinium

In order to enable a better understanding on the use of contrast agents containing gadolinium (Gd-based contrast agents) within the European Union, the European Commission has requested all manufacturers of contrast agents containing …

Dear Doctor Letter (Rote-Hand-Brief) on Xagrid® (active substance: anagrelide hydrochloride): Serious cardiovascular adverse events PDF, 466KB, File is accessible Date: 06. February 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: anagrelide hydrochloride

The pharmaceutical manufacturer is sending out information on a connection between Xagrid® and serious cardiovascular adverse events even in patients without known heart disease. This letter includes a reminder that Xagrid® is only indicated …

Dear Doctor Letter (Rote-Hand-Brief) on Tredaptive® (combination of niacin/laropiprant): Discontinuation of marketing PDF, 584KB, File is accessible Date: 22. January 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: niacin, laropiprant

The pharmaceutical manufacturer is sending out information that due to new data available from a clinical trial the marketing of the medicinal product Tredaptive® has been discontinued and that therefore treatment with this medicinal product …