EMEA-000278-PIP01-08-M01

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	EMEA-000278-PIP01-08-M01
Pharmaceutical form(s)	Suspension for injection in 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	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

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