European Union: EMA review of Zinbryta confirms medicine’s risks outweigh its benefits - Multiple sclerosis medicine no longer authorised and has been recalled from hospitals and pharmacies (English Only)
 
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the multiple sclerosis medicine Zinbryta (daclizumab beta) poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs. 

Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected. The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis. 

Healthcare professionals should continue monitoring patients who have been treated with Zinbryta in line with recommendations issued by EMA in March 2018. 

There are no immediate consequences of the PRAC’s review as Zinbryta is no longer authorised in the EU. On 27 March 2018, the marketing authorisation was withdrawn at the request of Biogen Idec Ltd, the company that marketed the medicine. Zinbryta is no longer available in hospitals and pharmacies in the EU. 

A full assessment report on the review will be published by EMA shortly. 

Please refer to the following website in EMA for details:http://www.ema.europa.eu/../news_detail_002955.jsp&mid=WC0b01ac058004d5c1 

In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by EMA, Medicines and Healthcare products Regulatory Agency (MHRA), The Therapeutic Goods Administration (TGA) and Health Canada, and was posted on the Drug Office website on 3 Mar 2018, 8 Mar 2018, 9 Mar 2018, 16 Mar 2018, 17 Mar 2018 and 14 Apr 2018. The DH will keep vigilant on any further update from the EMA and other health authorities. 

Ends/ Saturday, May 19, 2018 
Issued at HKT 12:00 

 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/ 
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