Emtriva

RSS

emtricitabine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

This EPAR was last updated on 04/12/2018

Authorisation details

Product details
Name
Emtriva
Agency product number
EMEA/H/C/000533
Active substance
emtricitabine
International non-proprietary name (INN) or common name
emtricitabine
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AF09
Publication details
Marketing-authorisation holder
Gilead Sciences Ireland UC
Revision
28
Date of issue of marketing authorisation valid throughout the European Union
24/10/2003
Contact address
Carrigtohill
County Cork, T45 DP77
Ireland

Product information

24/10/2018 Emtriva - EMEA/H/C/000533 - IG/0995

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.

This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.

When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.

Assessment history

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