Emtricitabine/Tenofovir disoproxil Krka

RSS

emtricitabine / tenofovir disoproxil

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

Overview

Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV‑1), a virus that causes acquired immune deficiency syndrome (AIDS). In addition, it may be used in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.

Emtricitabine/Tenofovir disoproxil Krka is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP). It should be used in combination with safer sex practices, such as use of condoms.

Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil. It is a ‘generic medicine’. This means that it contains the same active substances and works in the same way as a ‘reference medicine’ already authorised in the EU called Truvada.

This EPAR was last updated on 27/08/2019

Authorisation details

Product details
Name
Emtricitabine/Tenofovir disoproxil Krka
Agency product number
EMEA/H/C/004215
Active substance
  • emtricitabine
  • tenofovir disoproxil succinate
International non-proprietary name (INN) or common name
emtricitabine / tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR03
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
KRKA, d.d., Novo mesto
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
09/12/2016
Contact address
Smarjeska cesta 6
8501 Novo mesto
Slovenia

Product information

15/07/2019 Emtricitabine/Tenofovir disoproxil Krka - EMEA/H/C/004215 - IB/0012

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Treatment of HIV-1 infection

Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1

Pre-exposure prophylaxis (PrEP)

Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Assessment history

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