EMEA-000394-PIP01-08-M01 - paediatric investigation plan

Purified Tetanus Toxoid

Inactivated Type 1 Poliovirus (Mahoney)

Inactivated Type 2 Poliovirus (MEF-1)

Inactivated Type 3 Poliovirus (Saukett)

polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as prp-ompc

hepatitis B surface antigen recombinant

Purified Filamentous Haemagglutinin

purified pertussis toxoid

purified fimbriae types 2 and 3

purified pertactin

purified diphtheria toxoid

Key facts

• Active Substance:
  • Purified Tetanus Toxoid
  • Inactivated Type 1 Poliovirus (Mahoney)
  • Inactivated Type 2 Poliovirus (MEF-1)
  • Inactivated Type 3 Poliovirus (Saukett)
  • polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as prp-ompc
  • hepatitis B surface antigen recombinant
  • Purified Filamentous Haemagglutinin
  • purified pertussis toxoid
  • purified fimbriae types 2 and 3
  • purified pertactin
  • purified diphtheria toxoid
• Therapeutic area:
  Vaccines
• Decision number:
  P/0034/2012
• PIP number:
  EMEA-000394-PIP01-08-M01
• Pharmaceutical form(s):
  • Suspension for injection
  • Suspension for injection in pre-filled syringe
• Condition(s) / indication(s):
  Active immunisation against infectious diseases caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and poliovirus types 1, 2 and 3, against invasive disease caused by...
• Route(s) of administration:
  Intramuscular route
• Contact for public enquiries:

  Sanofi Pasteur MSD SNC

  E-mail: [e-mail]; Country: France; Phone: + 33 437284000

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/02/2012
• Compliance procedure number:
  EMEA-C-000394-PIP01-08-M01
• Compliance opinion date:
  10/10/2014
• Compliance outcome:
  Positive

Decision

P/0034/2012: EMA decision of 3 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for inactivated type 1 poliovirus (Mahoney) / purified fimbriae types 2 and 3 (EMEA-000394-PIP01...

AdoptedReference Number: EMA/8478/2012