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: piplan@spmsd.com
Country: France
Phone: + 33 437284000

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

Decision

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