Piramal Pharma arm, BrePco Biopharma get UKMHRA approval for Neoatricon in UK
Dublin: BrePco Biopharma Limited (BPCO) that develops products for the unique needs of paediatric patients and Piramal Critical Care (PCC), a division of Piramal Pharma Limited have announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a grant of a Marketing Authorisation for the use of Neoatricon - a paediatric strength solution for infusion of Dopamine Hydrochloride.
PCC has secured the commercialization rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions.
Developed by BPCO, Neoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of Dopamine Hydrochloride.
It 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.
Currently, there are no approved Dopamine Hydrochloride formulations specifically indicated for use in neonates, infants, or children, with off-label use remaining a common practice.
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