EMEA-003278-PIP01-22 - paediatric investigation plan

1-{6-[(4M)-4-(5-Chloro-6-methyl-1H-indazol-4-yl)-5-methyl-3-(1-methyl-1H-indazol-5-yl)-1H-pyrazol-1-yl]-2-azaspiro[3.3]heptan-2-yl}prop-2-en-1-one

Key facts

• Active substance:
  1-{6-[(4M)-4-(5-Chloro-6-methyl-1H-indazol-4-yl)-5-methyl-3-(1-methyl-1H-indazol-5-yl)-1H-pyrazol-1-yl]-2-azaspiro[3.3]heptan-2-yl}prop-2-en-1-one
• Therapeutic area:
  Oncology
• Decision number:
  P/0493/2022
• PIP number:
  EMEA-003278-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer (small cell and non-small cell lung 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:
  02/12/2022
• Compliance check done:
  No

Decision

P/0493/2022: EMA decision of 2 December 2022 on the granting of a product specific waiver for 1-{6-[(4M)-4-(5-Chloro-6-methyl-1H-indazol-4-yl)-5- methyl-3-(1-methyl-1H-indazol-5-yl)-1Hpyrazol- 1-yl]-2-azaspiro[3.3] [..] (EMEA-003278-PIP01-22)

Adopted Reference Number: EMA/853387/2022