EMEA-001105-PIP01-10-M06 - paediatric investigation plan

Dopamine (hydrochloride)

Key facts

• Active Substance:
  Dopamine (hydrochloride)
• Therapeutic area:
  • Cardiovascular diseases
  • Neonatology-Paediatric Intensive Care
• Decision number:
  P/0209/2022
• PIP number:
  EMEA-001105-PIP01-10-M06
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of vascular hypotensive disorders
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Brepco Biopharma Limited

  E-mail: [e-mail]; Tel.: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2023
• Compliance procedure number:
  EMEA-C-001105-PIP01-10-M06
• Compliance opinion date:
  14/10/2022
• Compliance outcome:
  Positive

Decision

P/0209/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dopamine (hydrochloride), (EMEA-001105-PIP01-10-M06)

AdoptedReference Number: EMA/365809/2022