MHRA-100559-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • MITAPIVAT SULFATE
Invented Name
PYRUKYND
PIP Number MHRA-100559-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet Age-appropriate oral solid dosage form (coated granules)
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of thalassaemia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Agios Netherlands B.V.
  • Country Netherlands
  • Tel 0018332288474
  • Email medinfo@agios.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MITAPIVAT SULFATE.pdf
Published Date 11/08/2026