EMEA-001448-PIP01-13-M03 - paediatric investigation plan

Nusinersen

Key facts

• Invented name:
  • Spinraza
  • Spinraza
• Active Substance:
  Nusinersen
• Therapeutic area:
  Neurology
• Decision number:
  P/023/2018
• PIP number:
  EMEA-001448-PIP01-13-M03
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of spinal muscular atrophy
• Route(s) of administration:
  Intrathecal use
• Contact for public enquiries:

  Biogen Idec Ltd

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/04/2018
• Compliance procedure number:
  EMEA-C-001448-PIP01-13-M03
• Compliance opinion date:
  29/06/2018
• Compliance outcome:
  Positive

Decision

P/0123/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nusinersen (Spinraza), (EMEA-001448-PIP01-13-M03)

AdoptedReference Number: EMA/194906/2018