EMEA-003526-PIP01-23 - paediatric investigation plan

recombinant varicella zoster virus glycoprotein E adjuvanted (CRV-101)

Key facts

• Active substance:
  recombinant varicella zoster virus glycoprotein E adjuvanted (CRV-101)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0379/2024
• PIP number:
  EMEA-003526-PIP01-23
• Pharmaceutical form(s):
  Powder and suspension for suspension for injection
• Condition(s) / indication(s):
  Prevention of varicella zoster virus (VZV) reactivation
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  25/10/2024
• Compliance check done:
  No

Decision

P/0379/2024 : EMA decision of 25 October 2024 on agreement of a paediatric investigation plan and on granting of a deferral and on the granting of a waiver for recombinant varicella zoster virus glycoprotein E adjuvanted (CRV-101) (EMEA-003526-PIP01-23)

Reference Number: EMA/465557/2024