Delstrigo
doravirine / lamivudine / tenofovir disoproxil
Table of contents
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.
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List item
Delstrigo : EPAR - Medicine overview (PDF/123.23 KB)
First published: 10/01/2019
Last updated: 12/04/2022
EMA/130020/2022 -
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List item
Delstrigo : EPAR - Risk-management-plan summary (PDF/78.34 KB)
First published: 10/01/2019
Last updated: 12/04/2022
Authorisation details
Product details | |
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Name |
Delstrigo
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Agency product number |
EMEA/H/C/004746
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
HIV Infections
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Anatomical therapeutic chemical (ATC) code |
J05AR
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Additional 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 | |
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Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
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Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
22/11/2018
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Contact address |
Waarderweg 39 |
Product information
10/10/2022 Delstrigo - EMEA/H/C/004746 - IG1535
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.