EMEA-001373-PIP01-12-M06 - paediatric investigation plan

bupropion hydrochloride

naltrexone hydrochloride

Key facts

• Invented name:
  Mysimba
• Active substance:
  • bupropion hydrochloride
  • naltrexone hydrochloride
• Therapeutic area:
  Metabolism and nutrition disorders
• Decision number:
  P/0280/2024
• PIP number:
  EMEA-001373-PIP01-12-M06
• 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:
  16/08/2024
• Compliance check done:
  No

Decision

P/0280/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for naltrexone (hydrochloride) / bupropion (hydrochloride) (Mysimba), (EMEA-001373-PIP01-12-M06)

Adopted Reference Number: EMA/343094/2024