BrePco Biopharma Limited (BPCO) and Piramal Critical Care (PCC) have announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorisation for Neoatricon®, the first paediatric-strength Dopamine Hydrochloride infusion solution.
Neoatricon® is designed to address the unmet needs of neonatal and paediatric patients. Developed by BPCO, it is a ready-to-use, sterile solution available in 1.5mg/mL (30 mL vial) and 4.5mg/mL (50 mL vial) concentrations. PCC holds the commercialization rights for the EU, UK, and Norway and will oversee its distribution in these regions.
Currently, there are no approved Dopamine Hydrochloride formulations specifically indicated for neonates, infants, or children. Off-label use is common, often leading to risks of incorrect dosing. The approval of Neoatricon® ensures precise dosing, minimizes preparation time, and enhances patient safety in neonatal and paediatric intensive care units (NICU & PICU).
This breakthrough approval sets a new standard in paediatric critical care, enabling faster and safer interventions in emergency settings. With Neoatricon®, healthcare professionals can now rely on a dedicated, age-appropriate formulation, reducing the burden of manual preparation.
About BrePco Biopharma & Piramal Critical Care
BPCO specializes in developing paediatric-focused treatments, while PCC is a global leader in critical care medicines. Their collaboration ensures that life-saving solutions reach the most vulnerable patients.
