EMEA-001850-PIP01-15 - paediatric investigation plan

Inactivated Type 1 poliovirus (Brunhilde)

Inactivated Type 3 Poliovirus (Saukett)

Inactivated Type 2 Poliovirus (MEF-1)

Key facts

• Active substance:
  • Inactivated Type 1 poliovirus (Brunhilde)
  • Inactivated Type 3 Poliovirus (Saukett)
  • Inactivated Type 2 Poliovirus (MEF-1)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0320/2015
• PIP number:
  EMEA-001850-PIP01-15
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of poliomyelitis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  21/12/2015
• Compliance check done:
  No

Decision

P/0320/2015: EMA decision of 21 December 2015 on the granting of a product-specific waiver for inactivated poliovirus type 1 (Brunhilde), inactivated poliovirus type 2 (MEF-1),inactivated poliovirus type 3 (Saukett) (EME...

Adopted Reference Number: EMA/792006/2015