Efavirenz Teva

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On 20 October 2011 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Efavirenz Teva 600 mg film-coated tablets indicated in antiviral combination treatment of human immunodeficiency virus 1 (HIV 1) infected adults, adolescents and children 3 years of age and older. The applicant for this medicinal product is Teva Pharma B.V. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Efavirenz Teva is efavirenz, a non-nucleoside reverse transcriptase inhibitor (ATC Code: J05A G03). Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).

Efavirenz Teva is a generic of Sustiva, which has been authorised in the EU since 28 May 1999. Studies have demonstrated the satisfactory quality of Efavirenz Teva, and its bioequivalence with the reference product Sustiva. 

A pharmacovigilance plan for Efavirenz Teva will be implemented as part of the marketing authorisation.

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

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR), and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit to risk balance for Efavirenz Teva and therefore recommends the granting of the marketing authorisation.

Name Language First published Last updated
CHMP summary of positive opinion for Efavirenz Tenz (English only) 2011-10-21  

Key facts

Product details for Efavirenz Teva
NameEfavirenz Teva
INN or common name

efavirenz

Therapeutic area HIV Infections
Active substance

efavirenz

Date opinion adopted20/10/2011
Company name

Teva Pharma B.V.

StatusPositive
Application typeInitial authorisation

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