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Questions & Answers

On 22 February 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Isentress. The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme Limited.

The CHMP adopted an extension to the existing indication to cover treatment of neonates. The new indication will be as follows[1]:

"Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, adolescents, children, toddlers and infants from the age of 4 weeks (see sections 4.2, 4.4, 5.1 and 5.2)."

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

[1] Removed text as strikethrough.

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Isentress (English only) 2018-02-23 2018-03-06

Key facts

Product details for Isentress
INN or common name


Therapeutic area HIV Infections
Active substance


Date opinion adopted22/02/2018
Company name

Merck Sharp & Dohme Limited

Application typePost authorisation