CHMP gives first opinion on paediatric extension
This article was originally published in Scrip
Executive Summary
For the first time, the CHMPhas recommended EU centralised approval for a paediatric line extension of a drug that was previously approved only at member state level. The committee has issued a positive opinion on a paediatric line extension of Merck Sharp & Dohme's antihypertensive Cozaar (losartan).