Lopinavir/Ritonavir Viatris (previously Ritonavir Mylan) (lopinavir;ritonavir)
- Region
- 🇪🇺 EU
- Active substance
- lopinavir;ritonavir
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 19 Nov 2015
- EU approval
- Thu 14 Jan 2016
- Designations
- Generic
- Application
- EMEA/H/C/004025
- ATC
- J05AR10
- Official record
- www.ema.europa.eu
Indication
Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years. The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Kaletra Authorised · AbbVie Deutschland GmbH & Co. KG
Follow Lopinavir/Ritonavir Viatris (previously Ritonavir 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.