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MYSIMBA

8mg/90 Milligram Tablet Prolonged Release

Orexigen Therapeutics Ireland LimitedEU/1/14/988/001

Main Information

Trade NameMYSIMBA
Active SubstancesNALTREXONE HYDROCHLORIDE
Strength8mg/90 Milligram
Dosage FormTablet Prolonged Release
Licence HolderOrexigen Therapeutics Ireland Limited
Licence NumberEU/1/14/988/001

Group Information

ATC CodeA08AA Centrally acting antiobesity products

Status

Authorised/WithdrawnAuthorised
Licence Issued26/03/2015
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of Licence

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Prescriber Checklist
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