EMEA-001971-PIP03-18-M02 - paediatric investigation plan

Larotrectinib

Key facts

• Invented name:
  Vitrakvi
• Active Substance:
  Larotrectinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0289/2022
• PIP number:
  EMEA-001971-PIP03-18-M02
• Pharmaceutical form(s):
  • Capsule (hard)
  • Oral solution
• Condition(s) / indication(s):
  Treatment of malignant neoplasms of the central nervous system
• Route(s) of administration:
  • Gastric use
  • Oral use
• Contact for public enquiries:

  Bayer AG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2022

Decision

P/0289/2022: EMA decision of 11 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for larotrectinib (Vitrakvi), (EMEA-001971-PIP03-18-M02)

Reference Number: EMA/630040/2022