EMEA-003223-PIP01-22 - paediatric investigation plan

N-(6-(((2R,3S)-3,4-dihydroxybutan-2-yl)oxy)-2-((4-fluorobenzyl)thio)pyrimidin-4-yl)-3-methylazetidine-1-sulfonamide (RIST-4721)

Key facts

• Active Substance:
  N-(6-(((2R,3S)-3,4-dihydroxybutan-2-yl)oxy)-2-((4-fluorobenzyl)thio)pyrimidin-4-yl)-3-methylazetidine-1-sulfonamide (RIST-4721)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0275/2022
• PIP number:
  EMEA-003223-PIP01-22
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of palmoplantar pustulosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/08/2022

Decision

P/0275/2022 : EMA decision on the granting of a product specific waiver for N-(6-(((2R,3S)-3,4-dihydroxybutan-2-yl)oxy)-2-((4- fluorobenzyl)thio)pyrimidin-4-yl)-3-methylazetidine-1-sulfonamide (RIST-4721), (EMEA-003223- PIP01-22)

AdoptedReference Number: EMA/659414/2022