Purified diphtheria toxoid / Purified tetanus toxoid / Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)] / Inactivated p...

Key facts

Invented name
PEDIACEL
Active substance
  • purified diphtheria toxoid
  • Purified Tetanus Toxoid
  • Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)]
  • Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett)
  • Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)
Therapeutic area
Vaccines
Decision number
P/64/2009
PIP number
Purified diphtheria toxoid / Purified tetanus toxoid / Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)] / Inactivated p...
Pharmaceutical form(s)
  • Suspension for injection (in a pre-filled syringe)
  • Suspension for injection in a vial
Condition(s) / indication(s)
Active immunisation against infectious diseases caused by Haemophilus influenzae type b, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and poliovirus types 1, 2 and 3
Route(s) of administration
Intramuscular use
Contact for public enquiries
Applicant: Sanofi Pasteur MSD SNC
E-mail: piplan@spmsd.com
Country: France
Phone: +33 437284000
Fax: Not available
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Compliance procedure number
EMEA-C-000278-PIP01-08-M01
Compliance opinion date
18/09/2009
Compliance outcome
positive

Decision

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