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.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
N/AATC Code
J05AG03
ATC Item
efavirenz
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| efavirenz | N/A | 依非韦伦 |
EMA Name
Efavirenz Teva
Medicine Name
Efavirenz Teva
Aliases
N/ANo risk management plan link.