EMEA-002685-PIP02-19-M01 - paediatric investigation plan

Diroximel fumarate (BIIB098)

Key facts

• Invented name:
  Vumerity
• Active Substance:
  Diroximel fumarate (BIIB098)
• Therapeutic area:
  Neurology
• Decision number:
  P/0413/2022
• PIP number:
  EMEA-002685-PIP02-19-M01
• Pharmaceutical form(s):
  Gastro-resistant capsule (hard)
• Condition(s) / indication(s):
  Treatment of multiple sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Biogen Netherlands B.V.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  29/09/2022

Decision

P/0413/2022 : EMA decision of 29 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for diroximel fumarate (BIIB098) (Vumerity) (EMEA-002685-PIP02-19-M01)

AdoptedReference Number: EMA/777575/2022