The Dutch Medicines Evaluation Board (MEB) has informed Eurand that the Decentralized Procedure (DCP) for registration of Paracetamol 250 and 500mg Orodispersible Tablets (ODT) in several EU countries, has been successfully completed.
Paracetamol (also known as acetaminophen) is a widely used analgesic (pain reliever) and antipyretic (fever reducer). Paracetamol ODT is indicated for symptomatic treatment of mild-to-moderate pain and/or fever.
The 500mg dose is indicated in adults and adolescents (over 12 years old) only, and the 250mg dose is for use in children from the age of four and adolescents only.
Gearoid Faherty, chairman and CEO of Eurand, said: We are pleased by the Dutch MEB’s decision regarding our Paracetamol ODT, and we look forward to receiving approval in the six individual countries later this year.
We believe our formulation will deliver this well-recognized pain reliever in a more patient friendly manner, particularly for those patients who have difficulty swallowing, he added.