EMA/PE/0000241119 - paediatric investigation plan

(12m)-(1s,2s)-n-((63s,4s,z)-11-ethyl-12-(2-((s)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11h-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide

Key facts

• Active substance:
  (12m)-(1s,2s)-n-((63s,4s,z)-11-ethyl-12-(2-((s)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11h-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide
• Therapeutic area:
  Neoplasms benign, malignant and unspecified (incl cysts and polyps)
• Decision number:
  EMA/PE/0000241119
• PIP number:
  EMA/PE/0000241119
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of pancreatic cancer
• Route(s) of administration:
  All routes of administration
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Nein

Decision

EMA/PE/0000241119 : EMA decision of 16 May 2025 on the granting of a product specific waiver for (12M)-(1S,2S)-N-((63S,4S,Z)-11-ethyl-12-(2-((S)-1-methoxyethyl)-5-(4-methylpiperazin...

Adopted Reference Number: EMADOC-1700519818-2116009