EMEA-002544-PIP01-18-M01 - paediatric investigation plan

Selpercatinib

Key facts

• Invented name:
  Retsevmo
• Active Substance:
  Selpercatinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0398/2021
• PIP number:
  EMEA-002544-PIP01-18-M01
• Pharmaceutical form(s):
  • Capsule (hard)
  • Age-appropriate dosage form
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Eli Lilly & Company Limited

  E-mail: [e-mail] ; Tel. [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/09/2021

Decision

P/0398/2021 : EMA decision of 30 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for selpercatinib (Retsevmo), (EMEA-002544-PIP01-18-M01)

AdoptedReference Number: EMA/531413/2021 corr