CHMP recommends a Paediatric Use Marketing Authorisation for Aqumeldi, intended for the treatment of heart failure in children
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 Aqumeldi, intended for the treatment of heart failure in children from birth to less than 18 years.
Aqumeldi will be available as a 0.25 mg orodispersible tablet. The active substance of Aqumeldi is enalapril maleate, an angiotensin converting enzyme inhibitor . It acts on the renin?angiotensin system, blocking the formation of angiotensin II. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
The benefits of Aqumeldi in children under 18 years of age are likely to be similar to those seen in adults with chronic heart failure, based on the pharmacokinetic response to the medicine. The most common side effects are cough, vomiting, microalbuminuria, hyperkalaemia, hypotension and postural dizziness. Aqumeldi is a hybrid medicine1 of Renitec which has been authorised in the EU since 06 September 1985. Aqumeldi contains the same active substance as Renitec, but is available at lower dosage strength and in a formulation more appropriate for children. Studies have demonstrated the satisfactory quality of Aqumeldi.
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