EMEA-002757-PIP01-19 - paediatric investigation plan

3-((1R,3s,5S)-3-((7-((5-methyl-1H-pyrazol-3-yl)amino)-1,6-naphthyridin-5-yl)amino)-8-azabicyclo[3.2.1]octan-8-yl)propanenitrile (TD-1473)

Key facts

• Active Substance:
  3-((1R,3s,5S)-3-((7-((5-methyl-1H-pyrazol-3-yl)amino)-1,6-naphthyridin-5-yl)amino)-8-azabicyclo[3.2.1]octan-8-yl)propanenitrile (TD-1473)
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0018/2021
• PIP number:
  EMEA-002757-PIP01-19
• Pharmaceutical form(s):
  • Tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of ulcerative colitis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Theravance Biopharma Ireland Limited

  Email: [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:
  27/01/2021

Decision

P/0018/2021 : 27 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver...(EMEA-002757-PIP01-19)

AdoptedReference Number: EMA/33224/2021