EMEA-003311-PIP01-22 - paediatric investigation plan

Tetanus toxoid

Key facts

• Invented name:
  Tetana
• Active Substance:
  Tetanus toxoid
• Therapeutic area:
  Vaccines
• Decision number:
  P/0043/2023
• PIP number:
  EMEA-003311-PIP01-22
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of infectious disease caused by Clostridium tetani
• Route(s) of administration:
  • Intramuscular use
  • Subcutaneous use
• Contact for public enquiries:

  IBSS Biomed S.A.

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2023

Decision

P/0043/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for tetanus toxoid (Tetana) (EMEA-003311-PIP01-22)

AdoptedReference Number: EMA/950370/2022