EMEA-003260-PIP02-23 - paediatric investigation plan

derivative of (3S,3'S,3a'S,10a'S)-3'-phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'- pyrrolo[2',3':4,5]pyrrolo[1,2-b]indazol]-2-one

Key facts

• Active Substance:
  derivative of (3S,3'S,3a'S,10a'S)-3'-phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'- pyrrolo[2',3':4,5]pyrrolo[1,2-b]indazol]-2-one
• Therapeutic area:
  Oncology
• Decision number:
  P/0236/2023
• PIP number:
  EMEA-003260-PIP02-23
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of biliary tract cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023

Decision

P/0236/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for Derivative of (3S,3'S,3a'S,10a'S)-3'- phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'-pyrrolo[2',3':4,5]pyrrolo[1,2-b]indazol]-2- one, (EMEA-003260-PIP02

Reference Number: EMA/238278/2023