Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018

News 30/11/2018

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of signals, risk management plans, periodic safety update reports and post-authorisation safety studies.

The Committee did not start or conclude any referral procedures. More information on all safety reviews currently under evaluation is provided in the ‘Ongoing referrals’ table.

Information on all topics discussed by the PRAC is available in the agenda below. 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 in January.

Ongoing referrals




Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC continued its assessment.

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