Atazanavir Krka (atazanavir)
- Region
- 🇪🇺 EU
- Active substance
- atazanavir
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Withdrawn
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 31 Jan 2019
- EU approval
- Mon 25 Mar 2019
- Designations
- Generic
- Application
- EMEA/H/C/004859
- ATC
- J05AE08
- Official record
- www.ema.europa.eu
Indication
Atazanavir Krka capsules, co-administered with low dose ritonavir, are 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). The choice of Atazanavir Krka in 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
- 🇪🇺 Atazanavir Viatris (previously Atazanavir Mylan) Authorised · Viatris Limited
- 🇪🇺 Reyataz Authorised · Bristol-Myers Squibb Pharma EEIG
- 🇪🇺 Evotaz Authorised · Bristol-Myers Squibb Pharma EEIG
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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.