Human Papillomavirus1 Type 6 L1 protein / Human Papillomavirus1 Type 11 L1 protein / Human Papillomavirus1 Type 16 L1 protein / Human Papillomavirus1 Type 18 L1 protein - paediatric investigation plan

human Papillomavirus1 Type 6 L1 protein

human Papillomavirus1 Type 11 L1 protein

human papillomavirus1 type 16 L1 protein

human Papillomavirus1 Type 18 L1 protein

Key facts

• Invented name:
  • Silgard
  • Silgard
• Active substance:
  • human Papillomavirus1 Type 6 L1 protein
  • human Papillomavirus1 Type 11 L1 protein
  • human papillomavirus1 type 16 L1 protein
  • human Papillomavirus1 Type 18 L1 protein
• Therapeutic area:
  Vaccines
• Decision number:
  P/111/2009
• PIP number:
  Human Papillomavirus1 Type 6 L1 protein / Human Papillomavirus1 Type 11 L1 protein / Human Papillomavirus1 Type 16 L1 protein / Human Papillomavirus1 Type 18 L1 protein
• 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:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/06/2009
• Compliance check done:
  No

Decision

P/111/2009: EMEA decision of 16 June 2009 on the agreement of a PIP and on the granting of a waiver for Human Papillomavirus1 Type6 L1 protein / Human Papillomavirus1 Type11 L1 protein /Human Papillomavirus1 Type16 L1 pr...

Adopted Reference Number: EMEA/351468/2009