Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-29 September 2017

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29/09/2017

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-29 September 2017

PRAC holds its first public hearing and starts re-examination

PRAC’s first public hearing: 65 participants, including 16 speakers

Patients, carers, doctors, pharmacists and academia shared their experience with valproate - a medicine that treats epilepsy, bipolar disorder and migraine - at the first public hearing held by the European Medicines Agency (EMA) at its offices in London on 26 September 2017. The public hearing is part of a review of the safety of using valproate-containing medicines in women and girls who are pregnant or of childbearing age by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

There is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that European Union (EU)-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

84 citizens registered to join the hearing either as speakers or observers and 65 of them attended the event. There were a total of 25 speaker contributions, grouped into 16 speaker slots, as highlighted in the agenda of the event.

Following the public hearing, the PRAC will reflect on the experiences and suggestions shared by the speakers and consider their input in assessing the safety of valproate. The PRAC will now convene follow-up meetings and is expected to issue its recommendation in the upcoming months.

A full recording of the event is available on EMA’s website (under the ‘Public hearing’ tab). A report on the public hearing will be published shortly. Based on the feedback from participants, the PRAC will establish a list of lessons learnt that will be applied to future public hearings.

PRAC requested to re-examine review of modified-release paracetamol

Following the PRAC’s recommendation of 1 September 2017, some of the marketing authorisation holders involved with this review have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC will start a re-examination, which is expected to conclude at the PRAC meeting of 27-30 November 2017.

Agenda

 
Agenda - PRAC draft agenda of meeting 25-29 September 2017

 

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Paracetamol-modified releasePRAC recommendation issued on 1 September 2017Following the PRAC’s recommendation of 1 September 2017, some of the marketing authorisation holders involved with this review have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC will start a re-examination, which is expected to conclude at the PRAC meeting of 27-30 November 2017.
Article-31 referral: Retinoid-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal productsUnder evaluationPRAC continued its assessment
Article-31 referral: Valproate and related substancesUnder evaluationPRAC continued its assessment and held a public hearing on 26 September 2017.
Article-20 referral: ZinbrytaUnder evaluationPRAC has issued provisional recommendations to ensure that Zinbryta continues to be used as safely as possible while a review of liver safety is ongoing.

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