At its February 4-6 meeting, the Pediatric Committee (PDCO) of the European Medicines Agency (EMEA) adopted two negative opinions on re-examinations of the refusals of Pediatric Investigation Plans, including waiver and deferral, for two products.
The PDCO confirmed two opinions on the refusal of a PIP for candesartan cilexetil in the therapeutic area of cardiovascular diseases, one as Blopress from Japan's Takeda, and one as Atacand Plus from Anglo-Swedish drug major AstraZeneca.
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