Atazanavir Viatris (previously Atazanavir Mylan) (atazanavir)
- Region
- 🇪🇺 EU
- Active substance
- atazanavir
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 23 Jun 2016
- EU approval
- Mon 22 Aug 2016
- Designations
- Generic
- Application
- EMEA/H/C/004048
- ATC
- J05AE08
- Official record
- www.ema.europa.eu
Indication
Atazanavir Viatris, co-administered with low dose ritonavir, is indicated for the treatment of HIV 1 infected adults and paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.Based on available virological and clinical data from adult patients, no benefit is expected in patients with strains resistant to multiple protease inhibitors (≥ 4 PI mutations). There are very limited data available from children aged 6 to less than 18 years. The choice of Atazanavir Viatrisin treatment experienced adult and paediatric patients should be based on individual viral resistance testing and the patient’s treatment history.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Reyataz Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Atazanavir Krka Withdrawn · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Evotaz Authorised · Bristol-Myers Squibb Pharma EEIG
Follow Atazanavir Viatris (previously Atazanavir Mylan)
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.