EMEA-000375-PIP01-08-M02

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Overview

Product details for Gardasil
Invented nameGardasil
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

Decision numberP/13/2010
PIP numberEMEA-000375-PIP01-08-M02
Pharmaceutical form(s)Suspension for injection, Suspension for injection in pre-filled syringe
Condition(s)/indication(s)

Infection by Human Papillomavirus

Route(s) of administrationIntramuscular use
PIP applicant

Applicant: Sanofi Pasteur MSD SNC
E-mail: piplan@spmsd.com
Country: France
Phone: +33 437284000

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-000375-PIP01-08-M02
Compliance check opinion date16/04/2010
Compliance check outcomePositive

Decision

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