EMEA-000972-PIP01-10-M05 - paediatric investigation plan

Laquinimod (sodium)

Key facts

• Active Substance:
  Laquinimod (sodium)
• Therapeutic area:
  Neurology
• Decision number:
  P/0143/2017
• PIP number:
  EMEA-000972-PIP01-10-M05
• Pharmaceutical form(s):
  Capsule, hard
• Condition(s) / indication(s):
  Treatment of relapsing remitting multiple sclerosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  07/06/2017

Decision

P/0143/2017: EMA decision of 7 June 2017 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for laquinimod (sodium) (EMEA-000972-PIP01-10-M05)

AdoptedReference Number: EMA/305260/2017