EMEA-000069-PIP05-16 - paediatric investigation plan

Mepolizumab

Key facts

• Invented name:
  • Nucala
  • Nucala
• Active Substance:
  Mepolizumab
• Therapeutic area:
  Pneumology-allergology
• Decision number:
  P/0119/2017
• PIP number:
  EMEA-000069-PIP05-16
• Pharmaceutical form(s):
  • Solution for injection
  • Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of nasal polyposis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  GSK Trading Services Limited

  United Kingdom; Tel.: [phone]; Fax: [phone]; E-mail: eu.paediatric-plans.gsk.com

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  05/05/2017

Decision

P/0119/2017: EMA decision of 5 May 2017 on the granting of a product-specific waiver for mepolizumab (Nucala), (EMEA-000069-PIP05-16)

AdoptedReference Number: EMA/255783/2017