Basic Information
Aqumeldi
Regulatory Information
EMEA/H/C/005731
Authorised
November 15, 2023
September 14, 2023
1
May 12, 2025
Company Information
d 01 v 4 a 3 ireland
Dublin Landings 2 North Wall Quay Dublin 1
Proveca Pharma Ltd.
Active Substances Detail
Enalapril (maleate)
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Treatment of heart failure.
Overview Summary
Aqumeldi is used in children and adolescents from birth to 17 years of age to treat heart failure (when the heart is not able to pump enough blood around the body). Aqumeldi contains the active substance enalapril and is a ‘hybrid medicine’. This means that it is similar to an authorised reference medicine containing the same active substance, but there are certain differences between the two. Aqumeldi is available at a lower dose than its reference medicine, Renitec, and in a different form that is appropriate for children.