Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August - 2 September 2016

News 02/09/2016

During its September meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed one ongoing safety referral. It did not initiate or conclude a referral. 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 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 including any studies or risk minimisation activities planned for marketed use. Post-authorisation activities also include risk management planning as well as the evaluation of periodic safety update reports (PSURs) to assess the safety and benefit-risk balance of a medicine throughout its lifecycle. 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 October.


Agenda - PRAC draft agenda of meeting 30 August - 2 September 2016

Ongoing referrals

Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC discussed and confirmed the timetable for the evaluation.
Article-20 procedure: Direct-acting antivirals for treatment of hepatitis C (interferon-free)Under evaluationPRAC continued its assessment.
Article-31 referral: Factor VIIIUnder 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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