P/13/2010

Key facts

Invented name
Gardasil
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
Therapeutic area
Vaccines
Decision number
P/13/2010
PIP number
P/13/2010
Pharmaceutical form(s)
  • Suspension for injection
  • Suspension for injection in pre-filled syringe
Condition(s) / indication(s)
Infection by Human Papillomavirus
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
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000375-PIP01-08-M02
Compliance opinion date
16/04/2010
Compliance outcome
positive

Decision

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