EMEA-001214-PIP06-20 - paediatric investigation plan

Benralizumab

Key facts

• Invented name:
  Fasenra
• Active Substance:
  Benralizumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0314/2020
• PIP number:
  EMEA-001214-PIP06-20
• Pharmaceutical form(s):
  • Age-appropriate dosage form for parenteral use
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of bullous pemphigoid
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  AstraZeneca AB

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/08/2020

Decision

P/0314/2020 : EMA decision of 14 August 2020 on the granting of a product specific waiver for benralizumab (Fasenra) (EMEA-001214-PIP06-20)

AdoptedReference Number: EMA/413751/2020