EMEA-003409-PIP01-23 - paediatric investigation plan

Benzo[b]thiophene-3-carbonitrile, 2-amino-4-[(4aS)-8-chloro-10-fluoro-2,3,4,4a,5,6-hexahydro-12-oxo-3-(1-oxo-2-propen-1-yl)-1H,12H-pyrazino[2,1-d][1,5]benzoxazocin-9-yl]-7-fluoro-, (4R)- (LY3537982)

Key facts

• Active substance:
  Benzo[b]thiophene-3-carbonitrile, 2-amino-4-[(4aS)-8-chloro-10-fluoro-2,3,4,4a,5,6-hexahydro-12-oxo-3-(1-oxo-2-propen-1-yl)-1H,12H-pyrazino[2,1-d][1,5]benzoxazocin-9-yl]-7-fluoro-, (4R)- (LY3537982)
• Therapeutic area:
  Oncology
• Decision number:
  P/0261/2023
• PIP number:
  EMEA-003409-PIP01-23
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoetic, and lymphoid tissue neoplasms)
  • Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2023
• Compliance check done:
  No

Decision

P/0261/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for benzo[b]thiophene-3-carbonitrile, 2-amino-4-[(4aS)-8- chloro-10-fluoro-2,3,4,4a,5,6-hexahydro-12-oxo-3-(1-oxo-2-propen-1-yl)-1H,12H-pyrazino[2,1- d][1,5]...

Reference Number: EMA/250883/2023