Tivicay (dolutegravir)
- Region
- 🇪🇺 EU
- Active substance
- dolutegravir
- Company
- ViiV Healthcare BV
- Status
- Authorised
- Therapeutic area
- HIV Infections
- CHMP opinion
- Thu 21 Nov 2013
- EU approval
- Thu 16 Jan 2014
- Application
- EMEA/H/C/002753
- ATC
- J05AX12
- Official record
- www.ema.europa.eu
Indication
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Dovato Authorised · ViiV Healthcare B.V.
- 🇪🇺 Triumeq Authorised · ViiV Healthcare B.V.
- 🇪🇺 Juluca Authorised · ViiV Healthcare B.V.
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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.