Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019

News 18/01/2019

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 safety signalsrisk management plansperiodic 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 February.

Ongoing referrals




Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC agreed on the need for a targeted meeting with patients and healthcare professionals.

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