EMEA-002781-PIP01-20 - paediatric investigation plan

Humanised Antibody Targeting the Inducible T cell Co-Stimulatory receptor

Key facts

• Active Substance:
  Humanised Antibody Targeting the Inducible T cell Co-Stimulatory receptor
• Therapeutic area:
  Oncology
• Decision number:
  P/0259/2020
• PIP number:
  EMEA-002781-PIP01-20
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Treatment of head and neck epithelial malignant neoplasms
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  GlaxoSmithKline (Ireland) Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/07/2020

Decision

P/0259/202: EMA decision of 17 July 2020 on the granting of a product specific waiver for humanised antibody targeting the inducible T cell costimulatory receptor (EMEA-002781-PIP01-20)

AdoptedReference Number: EMA/366507/2020