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Ethylex 50 mg film-coated tablets



Aop Orphan Pharmaceuticals GmbHPA0934/002/001

Main Information

Trade NameEthylex 50 mg film-coated tablets
Active SubstancesNaltrexone hydrochloride
Dosage FormFilm-coated tablet
Licence HolderAop Orphan Pharmaceuticals GmbH
Licence NumberPA0934/002/001

Group Information

ATC CodeN07BB Drugs used in alcohol dependence
N07BB04 naltrexone

Status

License statusAuthorised
Licence Issued20/04/2004
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2 and 4.4)
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
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