EMEA-003341-PIP01-22 - paediatric investigation plan

rubella virus Wistar RA 27/3 strain (live, attenuated)

varicella virus OKA strain (live, attenuated)

Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated)

Measles virus Schwarz strain (live, attenuated)

Key facts

• Active substance:
  • rubella virus Wistar RA 27/3 strain (live, attenuated)
  • varicella virus OKA strain (live, attenuated)
  • Mumps virus RIT 4385 strain, derived from Jeryl Lynn strain (live, attenuated)
  • Measles virus Schwarz strain (live, attenuated)
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0082/2023
• PIP number:
  EMEA-003341-PIP01-22
• Pharmaceutical form(s):
  Powder and solvent for solution for injection
• Condition(s) / indication(s):
  Prevention of measles, mumps, rubella and varicella
• Route(s) of administration:
  Parenteral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/03/2023
• Compliance check done:
  No

Decision

P/0082/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for Rubella virus Wistar RA 27/3 strain (live, attenuated) / Varicella virus OKA strain (live, attenuated), Mumps virus RIT 4385 strain.....(EMEA-003341-PIP01-22)

Reference Number: EMA/37965/2023