Highlights of EMA Pharmacovigilance committee July meeting

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded two safety reviews and gave a recommendation as part of a regular benefit-risk assessment review of a medicine at its July meeting.

Recommendation for oral methadone products containing povidone

The PRAC has concluded its review of oral methadone products containing the additive povidone. Oral methadone medicines are available as solutions or tablets. The PRAC recommends the suspension from the market of methadone oral solutions containing high molecular weight povidone. In addition, the PRAC recommends changes to the product information for tablets containing low molecular weight povidone to reinforce the message that tablets are for oral administration only and must not be taken in any other way.