| EMA number | EMEA/H/C/000249 |
| ATC code | J05AG03 |
| Authorisation | 28 May 1999 |
| Withdrawn | 1 February 2024 |
| Revision | 48 |
Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older. Sustiva 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 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 Sustiva.
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — HETERO LABS LTD V, approved 2022-01-24 (ANDA203053).
7,842 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.