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

Main Information

Trade NameMysimba
Active SubstancesNaltrexone hydrochloride
Dosage FormProlonged-release tablet
Licence HolderOrexigen Therapeutics Ireland Limited
Licence NumberEU/1/14/988/001

Group Information

ATC CodeA08AA Centrally acting antiobesity products
A08AA62 Bupropion and Naltrexone


License statusAuthorised
Licence Issued
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown


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

Educational Materials - HCP

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