Efavirenz Teva
Authorised
This medicine is authorised for use in the European Union
efavirenz
MedicineHumanAuthorised
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.
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.
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.
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).
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.
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.
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.
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.
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.
Product information
Latest procedure affecting product information: IB/0027/G
27/02/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Efavirenz Teva
- Active substance
- efavirenz
- International non-proprietary name (INN) or common name
- efavirenz
- Therapeutic area (MeSH)
- HIV Infections
- Anatomical therapeutic chemical (ATC) code
- J05AG03
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic 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.
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