EMEA-000482-PIP01-08-M06

Table of contents

Key facts

Invented name
Revestive
Active substance
teduglutide
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0479/2020
PIP number
EMEA-000482-PIP01-08-M06
Pharmaceutical form(s)
Powder and solvent for solution for injection
Condition(s) / indication(s)
Treatment of short bowel syndrome
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Takeda Pharmaceuticals International AG Ireland Branch

E-mail: medinfoemea@takeda.com
Tel: +44 (0) 3333 000181

Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000482-PIP01-08-M06
Compliance opinion date
26/03/2021
Compliance outcome
positive

Decision

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