🇪🇺 Raltegravir plus Truvada in European Union

EMA authorised Raltegravir plus Truvada on 19 December 2007

Marketing authorisation

EMA — authorised 19 December 2007

  • Application: EMEA/H/C/000860
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Isentress
  • Indication: Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.
  • Pathway: accelerated assessment
  • Status: approved

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Raltegravir plus Truvada in other countries

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

Frequently asked questions

Is Raltegravir plus Truvada approved in European Union?

Yes. EMA authorised it on 19 December 2007.

Who is the marketing authorisation holder for Raltegravir plus Truvada in European Union?

Merck Sharp & Dohme B.V. holds the EU marketing authorisation.