EMEA-000576-PIP03-12-M05

Key facts

Invented name
Xeljanz
Active substance
Tofacitinib
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0009/2021
PIP number
EMEA-000576-PIP03-12-M05
Pharmaceutical form(s)
  • Film-coated tablet
  • Oral solution
  • Prolonged-release film-coated tablet
  • Prolonged-release age-appropriate oral formulation
Condition(s) / indication(s)
Treatment of ulcerative colitis
Route(s) of administration
Oral use
Contact for public enquiries
Pfizer Europe MA EEIG

Tel. +44 1304 6466 07
E-mail: pip_enquiries@pfizer.com

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

Decision

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