EMEA-002480-PIP01-18 - paediatric investigation plan

tislelizumab

Key facts

• Active substance:
  tislelizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0142/2019
• PIP number:
  EMEA-002480-PIP01-18
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/04/2019
• Compliance check done:
  No

Decision

P/0142/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for tislelizumab (EMEA-002480-PIP01-18)

Adopted Reference Number: EMA/215378/2019