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


Darunavir Clonmel 600 mg film-coated tablets



Clonmel Healthcare LtdPA0126/299/002

Main Information

Trade NameDarunavir Clonmel 600 mg film-coated tablets
Active SubstancesDarunavir
Dosage FormFilm-coated tablet
Licence HolderClonmel Healthcare Ltd
Licence NumberPA0126/299/002

Group Information

ATC CodeJ05AE Protease inhibitors
J05AE10 darunavir

Status

License statusAuthorised
Licence Issued02/06/2017
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: Summary of Product Characteristics, section 4.2)
Marketing StatusMarketed

Documents

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