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
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2023
• Compliance check done:
  No

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)

Adopted Reference Number: EMA/950370/2022