EMEA-002876-PIP01-20 - paediatric investigation plan

Tauroursodeoxycholic acid

Sodium phenylbutyrate

Key facts

• Active Substance:
  • Tauroursodeoxycholic acid
  • Sodium phenylbutyrate
• Therapeutic area:
  Neurology
• Decision number:
  P/0495/2020
• PIP number:
  EMEA-002876-PIP01-20
• Pharmaceutical form(s):
  Powder for oral suspension
• Condition(s) / indication(s):
  Treatment of amyotrophic lateral sclerosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Drug Development and Regulation SL

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2020

Decision

P/0495/2020 : EMA decision of 22 December 2020 on the granting of a product specific waiver for tauroursodeoxycholic acid / sodium phenylbutyrate (EMEA-002876-PIP01-20)

AdoptedReference Number: EMA/598775/2020