During its August meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded 2 referrals and approved the list of participants and agenda for the planned public hearing on valproate. No new procedures were initiated at the meeting.
EU referral procedures for safety reasons – urgent EU procedures:
• Newly triggered procedures – None
• Ongoing procedures – None
• Procedures for Finalisation – None
• Planned public hearings – None
EU referral procedures for safety reasons – other EU referral procedures:
• Newly triggered procedures: None
• Ongoing procedures:
• Article-31 referral: Retinoid containing medicinal products – PRAC continued its assessment
• Article-31 referral: Quinolone and fluoroquinolone containing medicinal products – PRAC continued its assessment of liver safety
• Article-31 referral: Zinbryta – PRAC continued its evaluation
• Article-31 referral: Valproate and related substances – PRAC approved a list of participants and agenda for the public hearing due to take place on 26 September.
Procedures for finalisation:
• Article-31 referral: Factor VIII – following a re-examination, PRAC confirmed its May 2017 decision that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines used to treat haemophilia A; those derived from plasma and those produced from recombinant DNA technology.
• Article-31 referral: Paracetamol-modified release – PRAC has recommended paracetamol modified – or prolonged-release paracetamol products should be withdrawn from the market. The decision was taken in view of the difficulties in managing overdose in patients. After review of published data, PRAC confirmed the modified-release paracetamol tablets had a favourable benefit-risk profile. However, in cases of overdose the usual procedures developed for immediate-release paracetamol tablets were deemed to be unacceptable for modified-release tablets. This is due to the complex mechanism of drug release in the body. As a precaution, PRAC recommended suspension of the marketing authorisation for the prolonged-release or modified-release paracetamol products.
• Planned Public Hearings: PRAC approved the list of participants and agenda for the public hearing that will take place on 26 September for evaluation of valproate and related substances.
• Article 5(3) of Regulation (EC) No 726/2004: None.