🇪🇺 Doravirine/Lamivudine/Tenofovir in European Union

EMA authorised Doravirine/Lamivudine/Tenofovir on 22 November 2018

Marketing authorisation

Application: EMEA/H/C/004746
Marketing authorisation holder: Merck Sharp & Dohme B.V.
Local brand name: Delstrigo
Indication: Delstrigo is indicated for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir. Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.
Status: approved

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

Is Doravirine/Lamivudine/Tenofovir approved in European Union?

Yes. EMA authorised it on 22 November 2018.

Who is the marketing authorisation holder for Doravirine/Lamivudine/Tenofovir in European Union?

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