EMEA-001638-PIP02-21 - paediatric investigation plan

atezolizumab

Key facts

• Invented name:
  Tecentriq
• Active Substance:
  atezolizumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0384/2021
• PIP number:
  EMEA-001638-PIP02-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, hematopoietic and lymphoid tissue neoplasms and melanoma)
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021

Decision

P/0384/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for atezolizumab (Tecentriq), (EMEA-001638-PIP02-21)

AdoptedReference Number: EMA/440418/2021