EMEA-002684-PIP01-19-M01 - paediatric investigation plan

Mitapivat

Key facts

• Invented name:
  Pyrukynd
• Active Substance:
  Mitapivat
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0030/2022
• PIP number:
  EMEA-002684-PIP01-19-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age-appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of pyruvate kinase deficiency
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Agios Pharmaceuticals, Inc.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2022

Decision

P/0030/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mitapivat (EMEA-002684-PIP01-19-M01)

AdoptedReference Number: EMA/18783/2022