EMEA-002648-PIP01-19 - paediatric investigation plan

Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB)

Key facts

• Active Substance:
  Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB)
• Therapeutic area:
  Oncology
• Decision number:
  P/0094/2020
• PIP number:
  EMEA-002648-PIP01-19
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Roche Registration GmbH

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/03/2020

Decision

P/0094/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant anti-human CD20 and anti-human CD3 monoclonal antibody(RO7082859;CD20 CD3 TCB)

AdoptedReference Number: EMA/115521/2020