Delstrigo

RSS

doravirine / lamivudine / tenofovir disoproxil

Authorised
This medicine is authorised for use in the European Union.

Overview

Delstrigo is an antiviral medicine used to treat adults and adolescents from 12 years of age weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

The medicine is only used in patients where the virus has not developed resistance to medicines that work in the same way as Delstrigo’s active substances.

It is only used in adolescents if other HIV medicines without tenofovir disoproxil cannot be used because of side effects.

Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil.

This EPAR was last updated on 11/10/2022

Authorisation details

Product details
Name
Delstrigo
Agency product number
EMEA/H/C/004746
Active substance
  • doravirine
  • lamivudine
  • tenofovir disoproxil fumarate
International non-proprietary name (INN) or common name
  • doravirine
  • lamivudine
  • tenofovir disoproxil
Therapeutic area (MeSH)
HIV Infections
Anatomical therapeutic chemical (ATC) code
J05AR
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
22/11/2018
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

10/10/2022 Delstrigo - EMEA/H/C/004746 - IG1535

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antivirals for treatment of HIV infections, combinations

Therapeutic 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.

Assessment history

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