EMEA-001410-PIP02-17-M04 - paediatric investigation plan

Ixazomib

Key facts

• Invented name:
  Ninlaro
• Active Substance:
  Ixazomib
• Therapeutic area:
  Oncology
• Decision number:
  P/0237/2022
• PIP number:
  EMEA-001410-PIP02-17-M04
• Pharmaceutical form(s):
  • Powder for solution for injection or infusion
  • Capsule (hard)
• Condition(s) / indication(s):
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Treatment of multiple myeloma
• Route(s) of administration:
  • Intravenous use
  • Oral use
  • Gastric use
• Contact for public enquiries:

  Takeda Pharm A/S

  E-mail: [e-mail]​; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2022

Decision

P/0237/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ixazomib (Ninlaro), (EMEA-001410-PIP02-17-M04)

Reference Number: EMA/602320/2022