EMEA-003181-PIP01-22 - paediatric investigation plan

Peptide KLBPVQLWV / Peptide SMPPPGTRV / Peptide YLQLVFGIEV / Peptide RLLQETELV / Peptide YLSGADLNL / Peptide LLTFWNPPV / Peptide IMIGHLVGV / Peptide KVAEIVHFL / Peptide KVFGSLAFV / Pan HLA DR-binding epitope D-Ala-Lys-Cha-Val-Ala-Ala-Trp-Thr-Leu-Lys-Ala-Ala-D-Ala (OSE2101)

Key facts

• Active Substance:
  Peptide KLBPVQLWV / Peptide SMPPPGTRV / Peptide YLQLVFGIEV / Peptide RLLQETELV / Peptide YLSGADLNL / Peptide LLTFWNPPV / Peptide IMIGHLVGV / Peptide KVAEIVHFL / Peptide KVFGSLAFV / Pan HLA DR-binding epitope D-Ala-Lys-Cha-Val-Ala-Ala-Trp-Thr-Leu-Lys-Ala-Ala-D-Ala (OSE2101)
• Therapeutic area:
  Oncology
• Decision number:
  P/0227/2022
• PIP number:
  EMEA-003181-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of lung cancer (small cell and non-small cell lung cancer)
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  OSE Immunotherapeutics

  [e-mail] ; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/07/2022

Decision

P/0227/2022: EMA decision of 8 July 2022 on the granting of a product specific waiver for peptide KLBPVQLWV / peptide SMPPPGTRV / peptide YLQLVFGIEV / peptide RLLQETELV / peptide YLSGADLNL / peptide LLTFWNPPV / peptide IMIGHLVGV / peptide KVAEIVHFL / pept

AdoptedReference Number: EMA/575399/2022