EMEA-000654-PIP01-09-M02 - paediatric investigation plan

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
PIPHuman

Key facts

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
Decision date
Compliance procedure number
EMEA-C-000654-PIP01-09-M02
Compliance opinion date
Compliance outcome
Positive

Decision

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