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


Emtricitabine/Tenofovir disoproxil Accordpharma 200 mg/245 mg film-coated tablets



Accord Healthcare Ireland Ltd.PA2315/200/002

Main Information

Trade NameEmtricitabine/Tenofovir disoproxil Accordpharma 200 mg/245 mg film-coated tablets
Active SubstancesEmtricitabine
Tenofovir disoproxil
Dosage FormFilm-coated tablet
Licence HolderAccord Healthcare Ireland Ltd.
Licence NumberPA2315/200/002

Group Information

ATC CodeJ05AR Antivirals for treatment of HIV infections, combinations
J05AR03 tenofovir disoproxil and emtricitabine

Status

License statusAuthorised
Licence Issued28/06/2019
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)
Marketing StatusMarketed

Documents

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

Generics Information

Interchangeable List CodeIC0107-165-003
Interchangeable List DocumentPDF of Interchangeable List
« Back