EMEA-002930-PIP01-20 - paediatric investigation plan

anti-IL-7Rα monoclonal antibody (S95011/ OSE-127)

Key facts

• Active substance:
  anti-IL-7Rα monoclonal antibody (S95011/ OSE-127)
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0163/2021
• PIP number:
  EMEA-002930-PIP01-20
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Sjögren's syndrome
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/04/2021
• Compliance check done:
  No

Decision

P/0163/2021 : EMA decision of 14 April 2021 on the granting of a product specific waiver for anti-IL-7Rα monoclonal antibody (S95011 / OSE-127) (EMEA-002930-PIP01-20)

Reference Number: EMA/192347/2021