EMEA-000375-PIP01-08-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

Key facts

• Invented name:
  • Gardasil
  • 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:
  EMEA-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 administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  22/01/2010
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-000375-PIP01-08-M02
• Compliance opinion date:
  16/04/2010
• Compliance outcome:
  Positive

Decision

P/13/2010 EMA decision of 22 January 2010 on the acceptance of a modification of an agreed Paediatric Investigation Plan for Human Papillomavirus type 6 L1 protein/Human Papillomavirus type 11 L1 protein/Hum...

Adopted Reference Number: EMA/37131/2010