MHRA-100559-PIP01-22

Key Facts

Active Substance
Active Substance:
  • mitapivat
Invented Name
  • PYRUKYND
  • PYRUKYND
PIP Number MHRA-100559-PIP01-22
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
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
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 .pdf
Published Date 25/05/2023