EMEA-002859-PIP01-20 - paediatric investigation plan

Serplulimab

Key facts

• Active Substance:
  Serplulimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0471/2020
• PIP number:
  EMEA-002859-PIP01-20
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of lung cancer (small cell and non-small cell lung cancer)
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Shanghai Henlius Biotech, Inc.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/12/2020

Decision

P/0471/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for serplulimab (EMEA-002859-PIP01-20)

AdoptedReference Number: EMA/627309/2020