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 infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).

Delstrigo contains the active substances doravirine, lamivudine and tenofovir disoproxil. The medicine is not suitable for patients who are infected with HIV that is resistant to lamivudine, tenofovir disoproxil or to medicines in the same class as doravirine (non-nucleoside reverse transcriptase inhibitors or NNRTIs).

This EPAR was last updated on 10/01/2019

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 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
0
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

22/11/2018 Delstrigo - EMEA/H/C/004746 -

Contents

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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.

Assessment history

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