Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 January 2017

News 13/01/2017

At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed two ongoing safety reviews.

More information on all safety reviews currently under evaluation is provided in the table below. The Committee did not start or conclude a referral.

The PRAC also focused on the broad range of its responsibilities which cover all aspects of the risk management of the use of medicines. 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 at the beginning of February.


PDF icon Agenda - PRAC draft agenda of meeting 9-12 January 2017

Ongoing referrals

Article-31 referral: Factor VIIIUnder evaluationPRAC discussed a list of experts for the ad hoc expert group meeting
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC adopted a list of questions for the targeted meeting with patients and healthcare professionals (HCP)
Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactionsUnder evaluationPRAC continued its assessment
Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationPRAC continued its assessment
Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC continued its assessment
Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin)Under evaluationPRAC continued its assessment

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