EMEA-003317-PIP02-22 - paediatric investigation plan

Varicella virus OKA strain (live, attenuated)

Key facts

• Active Substance:
  Varicella virus OKA strain (live, attenuated)
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0066/2023
• PIP number:
  EMEA-003317-PIP02-22
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of Varicella Zoster virus disease
• Route(s) of administration:
  Parenteral use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals SA

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2024

Decision

P/0066/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for varicella virus OKA strain (live, attenuated) (EMEA-003317-PIP02-22)

Reference Number: EMA/84288/2023