Key facts

Invented name
  • Revestive
  • 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
Decision date
Compliance procedure number
EMEA-C-000482-PIP01-08-M06
Compliance opinion date
Compliance outcome
Positive

Decision

P/0479/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for teduglutide (Revestive) (EMEA-000482-PIP01-08-M06)

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