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FDA releases information Natalizumab (marketed as Tysabri) (English Only)
 
The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan. The relevant link for the news is: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182667.htm

Situation in Hong Kong: The above product is not registered in Hong Kong.

Ends/Friday, September 18, 2009
Issued at HKT 18:00

 
Related Information:
那他珠單抗(Tysabri▼):進行性多灶性腦白質病:更新建議以支持早期發現(給醫護專業人員的信,內容為英文) 上載於 2016-04-19
英國:那他珠單抗(Tysabri▼):進行性多灶性腦白質病 – 更新忠告以支持早期發現 上載於 2016-04-19
歐洲聯盟:歐洲藥物監管局確認建議以減低Tysabri的進行性多灶性腦白質病的腦炎的風險 上載於 2016-02-27
Tysabri(那他珠單抗):更新建議以減低進行性多灶性腦白質病的罕見腦炎的風險(給醫護專業人員的信,內容為英文) 上載於 2016-02-15
歐洲聯盟:更新建議以減低Tysabri的進行性多灶性腦白質病的罕見腦炎的風險 上載於 2016-02-13
歐洲聯盟:展開對Tysabri的審查 上載於 2015-10-12
美國:藥物安全通訊 - Tysabri (那他珠單抗):對進行性多灶性腦白質病有新的風險因素 上載於 2012-01-21
The United States: Tysabri (natalizumab) - Update of Healthcare Professional Inf... 上載於 2011-04-26
New safety information issued by Health Canada regarding Progressive Multifocal ... 上載於 2010-05-19
 
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