EMEA-001411-PIP01-12-M04

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Overview

Product details for Harvoni
Invented nameHarvoni
Active substance

Sofosbuvir / ledipasvir

Decision numberP/0063/2017
PIP numberEMEA-001411-PIP01-12-M04
Pharmaceutical form(s)Film-coated tablet; Age-appropriate dosage form, other; Age-appropriate oral solid dosage form
Condition(s)/indication(s)

Treatment of chronic hepatitis C

Route(s) of administrationOral use
PIP applicant

Gilead Sciences International Ltd.
United Kingdom
Tel. +44 (0)1223 897300
Fax +44 (0)1223897284
E-mail: regulatory.pip@gilead.com

Decision typePM: decision on the application for modification of an agreed PIP

Decision