Basic Information
J05AG03
efavirenz
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.
Overview Summary
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.
Active Substances (1)
efavirenz
Documents (8)
Efavirenz Teva : EPAR - Procedural steps taken and scientific information after authorisation
October 2, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
Efavirenz Teva : EPAR - Public assessment report
January 26, 2012
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Efavirenz Tenz
October 20, 2011
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Efavirenz Teva : EPAR - All Authorised presentations
January 26, 2012
AUTHORISED_PRESENTATIONS
Efavirenz Teva : EPAR - Product information
January 26, 2012
DRUG_PRODUCT_INFORMATION
Efavirenz Teva : EPAR - Summary for the public
January 26, 2012
OVERVIEW_DOCUMENT
Efavirenz Teva : EPAR - Public assessment report
January 26, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Efavirenz Tenz
October 20, 2011
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (8)
Question
How is Efavirenz Teva used?
Answer
Treatment with Efavirenz Teva should be started by a doctor who has experience in the management of HIV infection. Efavirenz Teva must be given in combination with other antiviral medicines. It is recommended that Efavirenz Teva be taken on an empty stomach and without food, preferably at bedtime.
The recommended dose of Efavirenz Teva for adults is 600 mg once a day. Efavirenz Teva tablets are not suitable for children weighing less than 40 kg. Efavirenz-containing capsules are available for these patients.
The dose of Efavirenz Teva needs to be reduced in patients taking voriconazole (used to treat fungal infections). Patients taking rifampicin (an antibiotic) may need to take a higher dose of Efavirenz Teva.
For full details, see the summary of product characteristics (also part of the EPAR).
Question
How does Efavirenz Teva work?
Answer
The active substance in Efavirenz Teva, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses. By blocking this enzyme, Efavirenz Teva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Efavirenz Teva does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Question
How has Efavirenz Teva been studied?
Answer
Because Efavirenz Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Sustiva. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Question
Why has Efavirenz Teva been approved?
Answer
The CHMP concluded that, in accordance with EU requirements, Efavirenz Teva has been shown to have comparable quality and to be bioequivalent to Sustiva. Therefore, the CHMP’s view was that, as for Sustiva, the benefit outweighs the identified risk. The Committee recommended that Efavirenz Teva be given marketing authorisation.
Question
What are the benefits and risks of Efavirenz Teva?
Answer
Because Efavirenz Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
Other information about Efavirenz Teva
Answer
The European Commission granted a marketing authorisation valid throughout the EU for Efavirenz Teva on 9 January 2012.
For more information about treatment with Efavirenz Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Question
What is Efavirenz Teva used for?
Answer
Efavirenz Teva is an antiviral medicine. It is used together with other antiviral medicines to treat adults and children aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
Question
What is Efavirenz Teva?
Answer
Efavirenz Teva is a medicine that contains the active substance efavirenz. It is available as tablets (600 mg).
Efavirenz Teva is a ‘generic medicine’. This means that Efavirenz Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Sustiva.