EMEA-001373-PIP01-12-M05 - paediatric investigation plan

bupropion hydrochloride

naltrexone hydrochloride

Key facts

• Invented name:
  Mysimba
• Active Substance:
  • bupropion hydrochloride
  • naltrexone hydrochloride
• Therapeutic area:
  Other
• Decision number:
  P/0294/2023
• PIP number:
  EMEA-001373-PIP01-12-M05
• Pharmaceutical form(s):
  Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of obesity
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2023

Decision

P/0294/2023 : EMA decision of 11 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for naltrexone (hydrochloride) / bupropion (hydrochloride) (Mysimba), (EMEA-001373-PIP01-12-M05)

Reference Number: EMA/336519/2023