EMA to review modified- and prolonged-release paracetamol
The European Medicines Agency is to review the benefits and risks of modified- and prolonged-release paracetamol medicines, which are available in several EU Member States and are designed to release paracetamol over a prolonged period of time. There are no authorised medicines of the specified pharmaceutical forms in the Republic of Croatia.
The paracetamol modified- and prolonged-release medicines are different from the usual immediate-release paracetamol medicines. Paracetamol-containing immediate release products have been authorised in all EU Member States, including the Republic of Croatia, and are not included in this review.
The standard procedures for assessing and managing overdose and poisoning with paracetamol are designed for the immediate-release products. In recent years there have been a number of cases of overdose with certain modified-release paracetamol medicines which indicate that the standard procedures may not be entirely suited to treat overdoses with these pharmaceutical forms.
The review will be carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), following a request from the Swedish medicines regulator, the Medical Products Agency. The PRAC will evaluate available evidence to determine the risk of overdose with modified- and prolonged-release paracetamol, and whether any additional measures need to be taken.
More about the medicine
Paracetamol is a medicine that has been used for many years to relieve pain and fever in adults and children.
This review covers the modified- and prolonged-release paracetamol medicines, that are designed to release paracetamol over a prolonged period of time. The review also covers modified- and prolonged-release medicines that contain paracetamol combined with other active substances.
There are no authorised medicines covered by this procedure in the Republic of Croatia.
More about the procedure
The review of modified- and prolonged-release paracetamol medicines has been initiated at the request of the Swedish Medical Products Agency, under Article 31 of Directive 2001/83/EC.
The review will be carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. The PRAC recommendations will then be sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which will adopt a position. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.