THE European Medicines Agency (EMA) has announced it will review the benefits and risks of paracetamol modified- and prolonged-release tablets, which are available in several EU Member States, and are designed to release paracetamol over a prolonged period of time.
The EMA said that in recent years it has seen a number of cases of overdose with certain modified-release paracetamol tablets, indicating that the standard procedures may not be entirely suited to treat overdoses with these newer products.
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.
CLICK HERE for more details about the investigation procedure.
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