The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Naltrexone Hydrochloride 50mg film-coated tablets



Accord Healthcare Ireland Ltd.PA2315/111/001

Main Information

Trade NameNaltrexone Hydrochloride 50mg film-coated tablets
Active SubstancesNaltrexone hydrochloride
Dosage FormFilm-coated tablet
Licence HolderAccord Healthcare Ireland Ltd.
Licence NumberPA2315/111/001

Group Information

ATC CodeN07BB Drugs used in alcohol dependence
N07BB04 naltrexone

Status

License statusAuthorised
Licence Issued21/05/2010
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 StatusMarketed

Documents

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