EMEA-003159-PIP01-21 - paediatric investigation plan

(2S) 4 [2 methoxyethyl [4 (5,6,7,8 tetrahydro 1,8 naphthyridin 2 yl)butyl] amino] 2 (quinazolin 4 ylamino)butanoic acid

Key facts

• Active Substance:
  (2S) 4 [2 methoxyethyl [4 (5,6,7,8 tetrahydro 1,8 naphthyridin 2 yl)butyl] amino] 2 (quinazolin 4 ylamino)butanoic acid
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0158/2022
• PIP number:
  EMEA-003159-PIP01-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of idiopathic pulmonary fibrosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pliant Therapeutics Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2022

Decision

P/0158/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for (2S) 4 [2 methoxyethyl [4 (5,6,7,8 tetrahydro 1,8 naphthyridin 2 yl)butyl] amino] 2 (quinazolin 4 ylamino)butanoic acid (EMEA-003159-PIP01-21)

AdoptedReference Number: EMA/169216/2022