EMEA-003270-PIP01-22 - paediatric investigation plan

Immunoglobulin G4 [224-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5713 γ4-chain), disulphide with human monoclonal REGN5713 κ-chain, dimer (REGN5713)

Immunoglobulin G4 [227-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5714 γ4-chain), disulphide with human monoclonal REGN5714 κ-chain, dimer (REGN5714)

Immunoglobulin G4 [228-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5715 γ4-chain), disulphide with human monoclonal REGN5715 κ-chain, dimer (REGN5715)

Key facts

• Active Substance:
  • Immunoglobulin G4 [224-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5713 γ4-chain), disulphide with human monoclonal REGN5713 κ-chain, dimer (REGN5713)
  • Immunoglobulin G4 [227-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5714 γ4-chain), disulphide with human monoclonal REGN5714 κ-chain, dimer (REGN5714)
  • Immunoglobulin G4 [228-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5715 γ4-chain), disulphide with human monoclonal REGN5715 κ-chain, dimer (REGN5715)
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0248/2023
• PIP number:
  EMEA-003270-PIP01-22
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of allergic rhinitis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regeneron Ireland DAC

  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:
  14/07/2023

Decision

P/0248/2023 : EMA decision of 14 July 2023 on agreement of a PIP and on granting of a deferral and a waiver for immunoglobulin G4 [224-proline], anti-(Betula alleghaniensis allergen Bet v 1) (human monoclonal REGN5713 γ4-chain), disulphide with human...

Reference Number: EMA/286493/2023