EMEA-000279-PIP01-08-M05

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Overview

Product details for Isentress
Invented nameIsentress
Active substance

Raltegravir

Decision numberP/0155/2016
PIP numberEMEA-000279-PIP01-08-M05
Pharmaceutical form(s)Film-coated tablet; Chewable tablet; Granules for oral suspension
Condition(s)/indication(s)

Treatment of human-immunodeficiency-virus (HIV-1) infection

Route(s) of administrationOral use
PIP applicant

Merck Sharp & Dohme (Europe) Inc.
Belgium
Tel.: +33180464738
E-mail: pip.information@merck.com

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-000279-PIP01-08-M05
Compliance check opinion date19/06/2017
Compliance check outcomePositive

Decision

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