Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015

13 July 2015

EMA to further clarify safety profile of human papillomavirus (HPV) vaccines

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of HPV vaccines to further clarify aspects of their safety profile. Like all medicines the safety of these vaccines is monitored by the PRAC. The review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome and postural orthostatic tachycardia syndrome. The review does not question that the benefits of HPV vaccines outweigh their risks.

More information is included in the table below.

PRAC votes to extend terms of its current Chair and Vice-chair for another three years

The PRAC has voted to prolong, for another three years, the mandates of Dr June Raine and Dr Álmath Spooner as Chair and Vice-chair respectively. Their new mandates will take effect from September 2015.

Agenda

Agenda - PRAC draft agenda of meeting 6-9 July 2015

Start of referral procedure

Human papillomavirus (HPV) vaccines
Article-20 procedure: Human papillomavirus (HPV) vaccines HPV vaccines - Article-20 procedure - Review started HPV vaccines - Article-20 procedure - Notification HPV vaccines - Article-20 procedure - PRAC list of questions HPV vaccines - Article-20 procedure - Timetable for the procedure