EMEA-002686-PIP01-19 - paediatric investigation plan

(2S)-2-[[2-[(4S)-4-(difluoromethyl)-2-oxo-oxazolidin3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide

Key facts

• Active substance:
  (2S)-2-[[2-[(4S)-4-(difluoromethyl)-2-oxo-oxazolidin3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide
• Therapeutic area:
  Oncology
• Decision number:
  P/0113/2020
• PIP number:
  EMEA-002686-PIP01-19
• Pharmaceutical form(s):
  • Tablet
  • Powder for oral solution
• Condition(s) / indication(s):
  Treatment of breast cancer
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2020
• Compliance check done:
  No

Decision

P/0113/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for (2S)-2-[[2-[(4S)-4-(difluoromethyl)-2-oxo-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide (EMEA-002686-PIP01-19)

Adopted Reference Number: EMA/124396/2020