CHMP positive for Neoatricon, intended for treatment of hypotension in neonates, infants and children under 18 years of age.-BrePco Biopharma Limited.
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. The applicant for this medicinal product is BrePco Biopharma Limited.
Neoatricon will be available as a 1.5 mg/mL and 4.5 mg/mL solution for infusion. The active substance of Neoatricon is dopamine hydrochloride, belonging to a therapeutic class of adrenergic and dopaminergic agents (ATC code: C01CA04). By stimulating adrenergic receptors of the sympathetic nervous system, dopamine hydrochloride increases the systemic vascular resistance and blood pressure in a dose?dependent manner.
The benefit of Neoatricon in the treatment of hypotension in neonates, infants and children <18 years old was demonstrated by published medical literature. the most common side effects are headache, ectopic heart beats, tachycardia, anginal pain, palpitation, hypotension, vasoconstriction, dyspnoea, nausea and vomiting.></18>
Neoatricon is a hybrid medicine1 of Sterile Dopamine Concentrate BP 40mg/mL, which has been authorised in the EU since 17 August 1989. Neoatricon contains the same active substance as Sterile Dopamine Concentrate BP 40mg/mL but is available in lower concentrations (1.5 mg/mL and 4.5 mg/mL). Studies have demonstrated the satisfactory quality of Neoatricon. Since Neoatricon is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product was not required.
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