EMEA-002554-PIP02-19 - paediatric investigation plan

Cilofexor

Key facts

• Active Substance:
  Cilofexor
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0294/2020
• PIP number:
  EMEA-002554-PIP02-19
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of primary sclerosing cholangitis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gilead Sciences International Ltd

  E-mail: [e-mail]; Tel. [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/08/2020

Decision

P/0294/2020 : EMA decision of 12 August 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cilofexor (EMEA-002554-PIP02-19)

AdoptedReference Number: EMA/377978/2020