Danish Pharmacovigilance Update, May 2011
01 June 2011
In this issue of Danish Pharmacovigilance Update:
- Risk of renal failure and proteinuria to be added to the summary of product characteristics of Afinitor® (everolimus), which is used for treatment of advanced renal cell carcinoma
- New warnings for Vectibix® (panitumumab) for treatment of metastatic colorectal carcinoma
- New warning for Tasigna® (nilotinib) for treatment of chronic myeloid leukaemia
- Tysabri® for treatment of multiple sclerosis and risk of progressive multifocal leukoencephalopathy (PML)
- Bricanyl® turbohaler, 200 dose inhaler to be replaced by the 100 dose inhaler due to risk of delivery of excess dose
- Octagam® to be marketed again
- Status on adverse reaction reports regarding contraceptive pills
- New study on the risk of venous thromboembolism from the use of Yasmin®
- The Danish Medicines Agency’s annual pharmacovigilance report 2010