EMEA-001373-PIP01-12-M06 - paediatric investigation plan
bupropion hydrochloride
naltrexone hydrochloride
PIPHuman
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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
- Contact for public enquiries
Orexigen Therapeutics Ireland Limited
E-mail: eu-regulatory@orexigen.com
Tel: +353 87 318 5448- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Ne