EMEA-001055-PIP01-10 - paediatric investigation plan

Human papilloma virus type 16 E6 071-095

human papilloma virus type 16 E7 064-098

human papilloma virus type 16 E6 055-080

human papilloma virus type 16 E6 001-032

human papilloma virus type 16 E6 091-122

Key facts

• Active Substance:
  • Human papilloma virus type 16 E6 071-095
  • human papilloma virus type 16 E7 064-098
  • human papilloma virus type 16 E6 055-080
  • human papilloma virus type 16 E6 001-032
  • human papilloma virus type 16 E6 091-122
• Therapeutic area:
  Oncology
• Decision number:
  P/61/2011
• PIP number:
  EMEA-001055-PIP01-10
• Pharmaceutical form(s):
  Powder for suspension for injection
• Condition(s) / indication(s):
  Treatment of vulvar intraepithelial neoplasia
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/03/2011

Decision

P/61/2011: EMA decision of 4 March 2011 on the granting of a product specific waiver for Human Papilloma Virus Type 16 E6 071-095 / Human Papilloma Virus Type 16 E7 064-098 / Human Papilloma Virus Type 16 E6 055 080 / Hu...

AdoptedReference Number: EMA/78577/2011