My HPRA: Register

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


Truvada 200 mg/245 mg film-coated tablets



Gilead Sciences Ireland UCEU/1/04/305/001-002

Main Information

Trade NameTruvada 200 mg/245 mg film-coated tablets
Active SubstancesEmtricitabine
Tenofovir disoproxil
Dosage FormFilm-coated tablet
Licence HolderGilead Sciences Ireland UC
Licence NumberEU/1/04/305/001-002

Group Information

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

Status

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 LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

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

Generics Information

Interchangeable ListEmtricitabine/Tenofovir disoproxil 200 mg/245 mg Film-coated Tablets
Interchangeable List CodeIC0107-165-003
Interchangeable List DocumentPDF of Interchangeable List
« Back
Follow medicine

Print