Sustiva (efavirenz)
- Region
- 🇪🇺 EU
- Active substance
- efavirenz
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- CHMP opinion
- Wed 24 Feb 1999
- EU approval
- Fri 28 May 1999
- Application
- EMEA/H/C/000249
- ATC
- J05AG03
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Stocrin Withdrawn · Merck Sharp & Dohme B.V.
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Efavirenz Teva Authorised · Teva B.V.
- 🇪🇺 Atripla Withdrawn · Gilead Sciences Ireland UC
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.