EMEA-001619-PIP03-16

Key facts

Active substance
filgotinib
Therapeutic area
Gastroentology-Hepatology
Decision number
P/0045/2019
PIP number
EMEA-001619-PIP03-16
Pharmaceutical form(s)
  • Film-coated tablet
  • Age-appropriate oral dosage form
Condition(s) / indication(s)
  • Treatment of Crohn's disease
  • Treatment of ulcerative colitis
Route(s) of administration
Oral use
Contact for public enquiries
Gilead Sciences International Limited

Tel. +44 (0)1223 897 300
E-mail: regulatory.pip@gilead.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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