Human Papillomavirus type 16 L1 protein / Human Papillomavirus type 18 L1 protein - paediatric investigation plan

human papillomavirus type 16 L1 protein

human papillomavirus type 18 L1 protein

Key facts

• Invented name:
  • Cervarix
  • Cervarix
• Active substance:
  • human papillomavirus type 16 L1 protein
  • human papillomavirus type 18 L1 protein
• Therapeutic area:
  Vaccines
• Decision number:
  P/11/2009
• PIP number:
  Human Papillomavirus type 16 L1 protein / Human Papillomavirus type 18 L1 protein
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Infection by Human Papillomavirus in females
• Route(s) of administration:
  Intramuscular injection
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  27/01/2009
• Compliance check done:
  No

Decision

P/11/2009: European Medicines Agency decision of 27 January 2009 on refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for Human Papillomavirus type 16 L1 protein,...

Adopted Reference Number: EMEA/30247/2009