EMEA-001036-PIP01-10 - paediatric investigation plan

Interferon alpha 2b

Key facts

• Active Substance:
  Interferon alpha 2b
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/336/2010
• PIP number:
  EMEA-001036-PIP01-10
• Pharmaceutical form(s):
  Vaginal cream
• Condition(s) / indication(s):
  Treatment of cervical intraepithelial neoplasia (CIN grade I and II)
• Route(s) of administration:
  Vaginal use
• Contact for public enquiries:

  Helix BioPharma Corp

  [e-mail]; Canada; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2010

Decision

P/336/2010: EMA decision of 22 December 2010 on the granting of a product specific waiver for interferon alpha 2b (EMEA-001036-PIP01-10)

AdoptedReference Number: EMA/683287/2010