MHRA-101494-PIP01-24-M01 (update)

Key Facts

Active Substance
Active Substance:
  • LUSPATERCEPT
Invented Name
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
  • Reblozyl
PIP Number MHRA-101494-PIP01-24-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection.
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of myelodysplastic syndromes. Treatment of beta-thalassaemia.
Route(s) of administration
Route(s) of administration:
  • SUBCUTANEOUS USE.
PIP applicant
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):LUSPATERCEPT.pdf
Published Date 03/10/2024