Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24-27 October 2016

News 28/10/2016

At its monthly meeting, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) discussed four ongoing safety reviews. More information on all safety reviews currently under evaluation is provided in the table below. The Committee did not initiate or conclude a referral.

The PRAC also focused on the broad spectrum 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 end of November.

Agenda

PDF iconAgenda - PRAC draft agenda of meeting 24-27 October 2016


Ongoing referrals

Procedure

Status

Update

Article-20 procedure: Direct-acting antivirals for treatment of hepatitis C (interferon-free)Under evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-31 referral: Factor VIIIUnder evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin)Under evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationPRAC continued its assessment
Article 31-referral: Retinoid-containing medicinal productUnder evaluationPRAC continued its assessment

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