Currently, the US FDA is not requiring changes to the prescribing information of Tysabri [natalizumab] or to the risk management plan

Author：  

Publisher： Adis International

ISSN： 0114-9954

Source： Reactions Weekly, Vol.1, Iss.1271, 2009-01, pp. : 2-2

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

Abstract

Related content

A possible fifth case of Tysabri [natalizumab]-associated progressive multifocal leukoencephalopathy (PML) has been reported to the US FDA.

By  

Reactions Weekly, Vol. 1, Iss. 1057, 2005-01 ,pp. : 2-2

Adis International

Access to resources Recommend Favorite

Changes to US Lovenox prescribing information

By  

Inpharma, Vol. 1, Iss. 1452, 2004-01 ,pp. : 17-17

Adis International

Access to resources Recommend Favorite

EMEA's CHMP has recommended updating the product information for natalizumab [Tysabri] to further increase the awareness about risk of progressive multifocal leukoencephalopathy (PML)

By  

Reactions Weekly, Vol. 1, Iss. 1222, 2008-01 ,pp. : 4-4

Adis International

Access to resources Recommend Favorite

US FDA strengthens isotretinoin risk management programme

By  

Inpharma, Vol. 1, Iss. 1501, 2005-01 ,pp. : 20-20

Adis International

Access to resources Recommend Favorite

Risk Management Policy and Black-Box Warnings: A Qualitative Analysis of US FDA Proceedings

By Cook Daniel M.  

Drug Safety, Vol. 32, Iss. 11, 2009-11 ,pp. : 1057-1066

Adis International

Access to resources Recommend Favorite