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443 results

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Dear Doctor Letter (Rote-Hand-Brief) on Pletal® (cilostazol): New safety information PDF, 3MB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: cilostazol

As the result of a review of the benefits and risks of cilostazol and in collaboration with the European Medicines Agency, the indications for medicinal products containing cilostazol have been restricted.

Dear Doctor Letter (Rote-Hand-Brief) on Tavor® pro injectione 2 mg solution for injection (lorazepam): Recall PDF, 119KB, File is accessible Date: 02. May 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lorazepam

Recall of Tavor® pro injectione 2 mg solution for injection due to possible contamination with glass splinters.

Increlex® 10 mg/ml solution for injection (mecasermin, recombinant human IGF-1): Temporary market shortage PDF, 208KB, File is accessible Date: 30. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mecasermin, recombinant human IGF-1

The company Ipsen Pharma GmbH is sending out information that the medicinal product Increlex® 10 mg/ml solution for injection will presumably be out of stock starting early August 2013. This shortage is due to manufacturing difficulties and …

Information Letter on CAELYX®: As of Monday 29 April 2013, supply with the medicinal product will return to normal PDF, 408KB, File is accessible Date: 23. April 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pegylated liposomal doxorubicin

Janssen-Cilag is sending out information that the supply with CAELYX® 2 mg/ml concentrate for solution for infusion is returning to regular availability and that the "CAELYX® Managed Access Programme" is being terminated.

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“).