Piramal Pharma and BrePco Biopharma Secure UKMHRA Approval for Neoatricon Significant Milestone for Pediatric Care

On March 21, 2025, Piramal Critical Care, part of Piramal Pharma, along with BrePco Biopharma from Ireland, announced that they have received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Neoatricon. This medication represents the first pediatric-strength solution for the infusion of Dopamine Hydrochloride, specifically designed for treating low blood pressure and heart rates in children.

Neoatricon is a ready-to-use, sterile solution available in two concentrations: 1.5 mg/mL in a 30 mL vial and 4.5 mg/mL in a 50 mL vial. The approval addresses a significant gap in pediatric care, as there are currently no approved formulations of Dopamine Hydrochloride specifically designed for neonates, infants, or children. Off-label use of existing formulations has been common, which can lead to dosing inaccuracies.

The introduction of Neoatricon ensures precise dosing, minimizes preparation time in neonatal and pediatric intensive care units, and facilitates quicker intervention in emergency situations. Peter DeYoung, CEO of Piramal Global Pharma, emphasized the importance of this milestone, stating that it marks a critical expansion into a new therapeutic area that will significantly enhance health outcomes for pediatric patients.

Piramal Critical Care will take responsibility for the distribution of Neoatricon across the EU, UK, and Norway markets. This strategic move is expected to improve the safety and efficacy of treatments available for children in critical care settings.

As healthcare providers and families await the rollout of this vital medication, the approval highlights the ongoing commitment to enhancing treatment options for vulnerable populations.