EMEA-003241-PIP01-22 - paediatric investigation plan

(S)-2-hydroxy-6-((4-(2-(2-hydroxyethyl) nicotinoyl) morpholin-3-yl) methoxy) benzaldehyde (GBT021601)

Key facts

• Active Substance:
  (S)-2-hydroxy-6-((4-(2-(2-hydroxyethyl) nicotinoyl) morpholin-3-yl) methoxy) benzaldehyde (GBT021601)
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0074/2023
• PIP number:
  EMEA-003241-PIP01-22
• Pharmaceutical form(s):
  • Age-appropriate oral solid dosage form
  • Tablet
• Condition(s) / indication(s):
  Treatment of sickle cell disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pfizer Europe MA EEIG

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

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  10/03/2023

Decision

P/0074/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (S)-2-hydroxy-6-((4-(2-(2-hydroxyethyl) nicotinoyl) morpholin-3-yl) methoxy) benzaldehyde

Reference Number: EMA/85287/2023