EMEA-001373-PIP01-12-M03

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Overview

Product details for Mysimba
Invented nameMysimba
Active substance

Naltrexone (hydrochloride) / bupropion (hydrochloride)

Decision numberP/0365/2017
PIP numberEMEA-001373-PIP01-12-M03
Pharmaceutical form(s)Prolonged-release tablet
Condition(s)/indication(s)

Treatment of obesity

Route(s) of administrationOral use
PIP applicant

Orexigen Therapeutics Ireland Limited
Tel. +1 8588758600
E-mail: ir@orexigen.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision

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