EMEA-003282-PIP01-22 - paediatric investigation plan

2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid

Key facts

• Active Substance:
  2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0482/2022
• PIP number:
  EMEA-003282-PIP01-22
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of systemic sclerosis
• Route(s) of administration:
  All routes of administration
• Contact for public enquiries:

  Horizon Therapeutics Ireland DAC

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  02/12/2022

Decision

P/0482/2022 : EMA decision of 2 December 2022 on the granting of a product specific waiver for 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid (EMEA-003282-PIP01-22)

AdoptedReference Number: EMA/871507/2022