EMEA-000654-PIP01-09-M02

Active substance	Human-papillomavirus-type-6 L1 protein human-papillomavirus-type-11 L1 protein human-papillomavirus-type-16 L1 protein human-papillomavirus-type-18 L1 protein human-papillomavirus-type-31 L1 protein human-papillomavirus-type-33 L1 protein human-papillomavirus-type-45 L1 protein human-papillomavirus-type-52 L1 protein human-papillomavirus-type-58 L1 protein
Therapeutic area	Vaccines
Decision number	P/0196/2013
PIP number	EMEA-000654-PIP01-09-M02
Pharmaceutical form(s)	Suspension for injection Suspension for injection in pre-filled syringe
Condition(s) / indication(s)	Prevention of infection by human papillomavirus
Route(s) of administration	Intramuscular use
Contact for public enquiries	Sanofi Pasteur MSD SNC piplan@spmsd.com Tel. +33 437284000
Decision type	PM: decision on the application for modification of an agreed PIP
Compliance procedure number	EMEA-C-000654-PIP01-09-M02
Compliance opinion date	17/01/2014
Compliance outcome	positive

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