EMA: Meeting highlights from the PRAC 4-7 May 2015
The Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May 2015 meeting.
Review of Tysabri started
The PRAC started a review of the multiple sclerosis medicine Tysabri (natalizumab). The aim of the review is to assess whether the advice given to healthcare professionals and patients on how to manage the known risk of progressive multifocal leukoencephalopathy (PML) with this medicine should be revised in the light of new scientific evidence.
Review of inhaled corticosteroids used to treat chronic obstructive pulmonary disease started
The Committee also began a review of inhaled corticosteroids used to treat chronic obstructive pulmonary disease (COPD). The review aims to further evaluate the known risk of pneumonia when these medicines are used for COPD.
For an overview of all information available following the meeting of the PRAC, see the table below.
Posted on the EMA website on 8 May 2015