EMEA-000482-PIP01-08-M04

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Overview

Product details for Revestive
Invented nameRevestive
Active substance

Teduglutide

Decision numberP/0351/2017
PIP numberEMEA-000482-PIP01-08-M04
Pharmaceutical form(s)Powder and solvent for solution for injection
Condition(s)/indication(s)

Treatment of short bowel syndrome

Route(s) of administrationSubcutaneous use
PIP applicant

Shire Pharmaceuticals Ireland Limited
Tel. +44 (0)8008 38470
E-mail: medinfoeuceemea@shire.com

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

Decision