Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2016

News 10/06/2016

During its June meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) did not initiate or conclude a safety referral. It discussed two ongoing referrals. More information on all ongoing referrals is included in the table below.

The Committee focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines. The PRAC's full range of work includes pre-authorisation activities, such as the assessment of risk-management plans for medicines under evaluation, as well as post-authorisation activities, such as the evaluation of periodic safety update reports (PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected. The PRAC also evaluates safety signals, a key public-health function that ensures that new or changing safety issues are rapidly detected, evaluated and, when appropriate, product-labelling changes or restrictions are introduced for the benefit of patients.

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 in July.

Agenda

PDF iconAgenda - PRAC draft agenda of meeting 6-9 June 2016


Ongoing referrals

ProcedureStatusUpdate
Article-20 procedure: CanagliflozinUnder evaluationPRAC continued its assessment.
Article-20 referral: Direct-acting antivirals for treatment of hepatitis C (interferon-free)Under evaluationPRAC continued its assessment.
Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-20 referral: ZydeligUnder evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.

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