EMEA-002029-PIP01-16-M03 - paediatric investigation plan

Tremelimumab

Key facts

• Active Substance:
  Tremelimumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0367/2022
• PIP number:
  EMEA-002029-PIP01-16-M03
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue)
  • Treatment of malignant neoplasms of lymphoid tissue
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  AstraZeneca AB

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/09/2022

Decision

P/0367/2022: EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tremelimumab (EMEA-002029-PIP01-16-M03)

Reference Number: EMA/697759/2022