EMEA-001426-PIP01-13-M03 - paediatric investigation plan

recombinant varicella zoster virus glycoprotein E

Key facts

• Invented name:
  Shingrix
• Active substance:
  recombinant varicella zoster virus glycoprotein E
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0328/2024
• PIP number:
  EMEA-001426-PIP01-13-M03
• Pharmaceutical form(s):
  • Powder and suspension for suspension for injection
  • Suspension for injection
• Condition(s) / indication(s):
  Prevention of varicella zoster virus (VZV) reactivation
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/09/2024
• Compliance check done:
  No

Decision

P/0328/2024 : EMA decision of 13 September 2024 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant varicella zoster virus (VZV) glycoprotein E (Shingrix), (EMEA-001426-PIP01-13-M03)

Adopted Reference Number: EMA/413604/2024