EMEA-002096-PIP01-16-M03 - paediatric investigation plan

Entrectinib

Key facts

• Invented name:
  Rozlytrek
• Active Substance:
  Entrectinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0351/2021
• PIP number:
  EMEA-002096-PIP01-16-M03
• Pharmaceutical form(s):
  • Capsule, hard
  • Coated granules
• 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
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2021
• Compliance procedure number:
  EMEA-C-002096-PIP01-16-M03
• Compliance opinion date:
  24/02/2023
• Compliance outcome:
  Positive

Decision

P/0351/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for entrectinib (Rozlytrek), (EMEA-002096-PIP01-16-M03)

AdoptedReference Number: EMA/418758/2021