Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2015

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08/05/2015

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (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.

Agenda

 
Agenda - PRAC draft agenda of meeting 4-7 May 2015


Start of referral procedure

Tysabri

Article-20 procedure: Tysabri

 

Review started
Referral notification
PRAC list of questions
Timetable for the procedure

 

Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

Article-31 referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

 

Review started
Referral notification
PRAC list of questions
Timetable for the procedure

 

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Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu