EMEA-001373-PIP01-12-M04

Table of contents

Key facts

Invented name
Mysimba
Active substance
  • bupropion hydrochloride
  • naltrexone hydrochloride
Therapeutic area
Other
Decision number
P/0390/2021
PIP number
EMEA-001373-PIP01-12-M04
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

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