Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 November - 3 December 2015
Ongoing referrals
During its December meeting, the PRAC discussed two ongoing referrals. More information on all ongoing referrals is included in the table below. The PRAC did not initiate or conclude a safety referral.
Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting, held from 11-14 January 2016.
Agenda
Agenda - PRAC draft agenda of meeting 30 November - 3 December 2015
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Ongoing referrals
Procedure | Status | Update |
|---|---|---|
Under evaluation | PRAC discussed feedback from the Scientific Advisory Group (SAG), adopted a list of outstanding issues, and updated the referral timetable | |
Article-31 procedure: Fusafungine containing medicinal products for oromucosal and nasal use | Under evaluation | PRAC agreed to convene a Scientific Advisory Group (SAG), adopted a list of outstanding issues, and updated the referral timetable |
Under evaluation | PRAC continued its assessment | |
| Article-20 procedure: SGLT2 inhibitors | Under evaluation | PRAC continued its assessment |