MHRA-100608-PIP01-22-M01 (update)

Key Facts

Active Substance
Active Substance:
  • mitapivat
Invented Name
  • PYRUKYND
  • PYRUKYND
PIP Number MHRA-100608-PIP01-22-M01 (update)
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 pyruvate kinase deficiency
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
Yes
Compliance Check Decision Date
Compliance opinion date
15/09/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100608-PIP01-22-M01-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):mitapivat.pdf
Published Date 07/12/2022