🇪🇺 Dolutegravir Sodium Monohydrate in European Union

EMA authorised Dolutegravir Sodium Monohydrate on 16 January 2014

Marketing authorisation

EMA — authorised 16 January 2014

  • Application: EMEA/H/C/002753
  • Marketing authorisation holder: ViiV Healthcare BV
  • Local brand name: Tivicay
  • 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.
  • Status: approved

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Dolutegravir Sodium Monohydrate in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Infectious Disease approved in European Union

Frequently asked questions

Is Dolutegravir Sodium Monohydrate approved in European Union?

Yes. EMA authorised it on 16 January 2014.

Who is the marketing authorisation holder for Dolutegravir Sodium Monohydrate in European Union?

ViiV Healthcare BV holds the EU marketing authorisation.