EMEA-002350-PIP05-23 - paediatric investigation plan

Deucravacitinib

Key facts

• Invented name:
  Sotyktu
• Active Substance:
  Deucravacitinib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0250/2023
• PIP number:
  EMEA-002350-PIP05-23
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of Sjögren's syndrome
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Bristol-Myers Squibb Pharma EEIG

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2023

Decision

P/0250/2023 : EMA decision of 14 July 2023 on the granting of a product specific waiver for deucravacitinib (Sotyktu), (EMEA-002350-PIP05-23)

Reference Number: EMA/302856/2023