Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Delstrigo   
Auth. number : EU/1/18/1333
Active substance : doravirine / lamivudine / tenofovir disoproxil
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AR - Antivirals for treatment of hiv infections, combinations
Chemical substance: J05AR24 - lamivudine, tenofovir disoproxil and doravirine
(See WHO ATC Index)
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
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
26/11/2018 Centralised - Authorisation EMEA/H/C/4746 (2018)7960 of 22/11/2018
11/02/2019 Centralised - Variation EMEA/H/C/4746/IA/04
11/02/2019 Centralised - Variation EMEA/H/C/4746/IA/04
28/02/2019 Centralised - Variation EMEA/H/C/4746/II/01