🇪🇺 DOPAMINE HYDROCHLORIDE in European Union

EMA authorised DOPAMINE HYDROCHLORIDE on 27 May 2024

Marketing authorisation

EMA — authorised 27 May 2024

  • Application: EMEA/H/C/006044
  • Marketing authorisation holder: BrePco Biopharma Limited
  • Local brand name: Neoatricon
  • Indication: Treatment of hypotension in haemodynamically unstable neonates, infants and children < 18 years
  • Status: approved

The European Medicines Agency (EMA) granted marketing authorisation for Neoatricon (DOPAMINE HYDROCHLORIDE) on 27 May 2024. This authorisation allows BrePco Biopharma Limited to market the product in the European Union for the treatment of hypotension in haemodynamically unstable neonates, infants, and children under 18 years. The product will be available under the brand name Neoatricon.

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DOPAMINE HYDROCHLORIDE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is DOPAMINE HYDROCHLORIDE approved in European Union?

Yes. EMA authorised it on 27 May 2024.

Who is the marketing authorisation holder for DOPAMINE HYDROCHLORIDE in European Union?

BrePco Biopharma Limited holds the EU marketing authorisation.