Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 September 2015

11 September 2015

Start of review of nasal and mouth sprays containing fusafungine

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of nasal and mouth sprays containing the antibiotic fusafungine, used to treat infections of the upper airways. The PRAC aims to review the available data on the benefits and risks of these medicines and issue an opinion on their marketing authorisations across the European Union.

More information is included in the table below.

Agenda

Agenda - PRAC draft agenda of meeting 7-10 September 2015

Start of referral procedure

Fusafungine containing medicinal products for oromucosal and nasal use
Article-31 procedure: Fusafungine containing medicinal products for oromucosal and nasal use Fusafungine Article-31 referral - Review started Fusafungine Article-31 referral - Notification Fusafungine Article-31 referral - PRAC list of questions Fusafungine Article-31 referral - Timetable for the procedure