Piramal Pharma unit gets approval to market Neoatricon in UK

21 Mar 2025 , 11:14 AM

Piramal Pharma Limited stated that Piramal Critical Care (PCC) and Ireland-based BrePco Biopharma Ltd (BPCO) have received approval from UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Naeoatricon. It is a first pediatric-strength dopamine hydrochloride infusion for treatment of hypotension in neonates, infants, and children.

Piramal Critical Care has reserved commercialisation rights for the EU, UK, and Norway and will look after Neoatricon in these regions. The regulatory approval marks a major expansion for PCC into paediatric critical care.

Neoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of dopamine hydrochloride. The drug is developed by BrePco Biopharma. The drug is available in a concentration of 1.5mg/mL in a 30 mL vial and a higher strength containing 4.5mg/mL in a 50 mL vial.

At present, there are no approved dopamine hydrochloride formulations specifically indicated to be used in neonates, infants, or children, with off-label use remaining a common practice.

The approval of Neoatricon addresses this crucial gap by ensuring accurate dosing, minimising the risk of under or overdosing, and cutting the preparation time in neonatal and pediatric intensive care units (NICU & PICU), facilitating faster intervention in emergency settings. 

With this approval, Neoatrican marks a new standard in paediatric critical care.

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