Tenofovir disoproxil Zentiva (tenofovir disoproxil)
- Region
- 🇪🇺 EU
- Active substance
- tenofovir disoproxil
- Company
- Zentiva k.s.
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 21 Jul 2016
- EU approval
- Thu 15 Sep 2016
- Designations
- Generic
- Application
- EMEA/H/C/004120
- ATC
- J05AF07
- Official record
- www.ema.europa.eu
Indication
HIV?1 infection Tenofovir disoproxil Zentiva is indicated in combination with other antiretroviral medicinal products for the treatment of HIV?1 infected adults. In adults, the demonstration of the benefit of tenofovir disoproxil in HIV?1 infection is based on results of one study in treatment?naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which tenofovir disoproxil was added to stable background therapy (mainly tritherapy) in antiretroviral pre?treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml). Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV?1 infected adolescents, with NRTI (nucleotide reverse transcriptase inhibitor) resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. The choice of Tenofovir disoproxil Zentiva to treat antiretroviral?experienced patients with HIV?1 infection should be based on individual viral resistance testing and/or treatment history of patients. Hepatitis B infection Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis (see section 5.1); evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1); decompensated liver disease (see sections 4.4, 4.8 and 5.1). Tenofovir disoproxil Zentiva is indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis (see sections 4.4, 4.8 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Delstrigo Authorised · Merck Sharp & Dohme B.V.
- 🇪🇺 Tenofovir disoproxil Viatris (previously Tenofovir disoproxil Mylan) Authorised · Viatris Limited
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Eviplera Authorised · Gilead Sciences International Ltd
- 🇪🇺 Viread Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Truvada Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Stribild Authorised · Gilead Sciences Ireland UC
- 🇪🇺 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Krka d.d. Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Emtricitabine/Tenofovir disoproxil Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
Follow Tenofovir disoproxil Zentiva
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.