EMEA-000234-PIP02-14 - paediatric investigation plan

human papillomavirus type 18 L1 protein

human papillomavirus type 16 L1 protein

Key facts

• Invented name:
  • Cervarix
  • Cervarix
• Active Substance:
  • human papillomavirus type 18 L1 protein
  • human papillomavirus type 16 L1 protein
• Therapeutic area:
  Vaccines
• Decision number:
  P/0008/2015
• PIP number:
  EMEA-000234-PIP02-14
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of infection by human papillomavirus
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals S.A. (Belgium)

  Tel. [phone]; Email: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/01/2015

Decision

P/0008/2015: EMA decision of 30 January 2015 on the granting of a product specific waiver for human papillomavirus type 18 L1 protein / human papillomavirus type 16 L1 protein (Cervarix), (EMEA-000234-PIP02-14)

AdoptedReference Number: EMA/793136/2014