Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 November - 3 December 2015

News 04/12/2015

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

PDF iconAgenda - PRAC draft agenda of meeting 30 November - 3 December 2015


Ongoing referrals

Procedure

Status

Update

Article-20 procedure: Tysabri

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

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

Under evaluation

PRAC continued its assessment

Article-20 procedure: SGLT2 inhibitorsUnder evaluationPRAC continued its assessment

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