EMEA-001638-PIP01-14-M02 - paediatric investigation plan

atezolizumab

Key facts

• Invented name:
  Tecentriq
• Active Substance:
  atezolizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0207/2019
• PIP number:
  EMEA-001638-PIP01-14-M02
• 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 tumours, haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/06/2019
• Compliance procedure number:
  EMEA-C-001638-PIP01-14-M02
• Compliance opinion date:
  20/09/2019
• Compliance outcome:
  Positive

Decision

P/0207/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for atezolizumab (Tecentriq), (EMEA-001638-PIP01-14-M02)

AdoptedReference Number: EMA/287009/2019