Efavirenz Teva

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efavirenz

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

Overview

This is a summary of the European public assessment report (EPAR) for Efavirenz Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Efavirenz Teva.

This EPAR was last updated on 17/10/2019

Authorisation details

Product details
Name
Efavirenz Teva
Agency product number
EMEA/H/C/002352
Active substance
efavirenz
International non-proprietary name (INN) or common name
efavirenz
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AG03
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
Teva B.V.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
09/01/2012
Contact address

Swensweg 5
2031GA Haarlem
The Netherlands

Product information

20/09/2019 Efavirenz Teva - EMEA/H/C/002352 - IB/0021/G

Contents

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Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.

Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.

Assessment history

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