MHRA-100855-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • DOPAMINE HYDROCHLORIDE
Invented Name
Neoatricon
PIP Number MHRA-100855-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion
Therapeutic area
  • Cardiovascular Diseases
  • Neonatology - Paediatric Intensive Care
Conditions / Indications
Conditions / Indications:
  • Treatment of vascular hypotensive disorders
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • BrePco Biopharma Ltd
  • Country Ireland
  • Tel 00353526180664
  • Email info@ivowen.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
08/03/2023
Compliance Check Procedure Number
Compliance procedure number
MHRA-100813-PIP01-22-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):DOPAMINE HYDROCHLORIDE.pdf
Published Date 25/05/2023