EMEA-002651-PIP01-19 - paediatric investigation plan

glibenclamide

Key facts

• Active Substance:
  glibenclamide
• Therapeutic area:
  Neurology
• Decision number:
  P/0043/2020
• PIP number:
  EMEA-002651-PIP01-19
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of large hemispheric infarction
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Biogen Idec Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2020

Decision

P/0043/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for glibenclamide (EMEA-002651-PIP01-19)

AdoptedReference Number: EMA/12840/2020