EMA/CHMP/61250/2024
Committee for Medicinal Products for Human Use (CHMP) Summary of opinion1 (initial authorisation):
“Neoatricon® dopamine hydrochloride: On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a paediatric use marketing authorisation (PUMA) for the medicinal product Neoatricon, intended for treatment of hypotension in neonates, infants and children under 18 years of age.”