MHRA-101310-PIP01-23

Key Facts

Active Substance
Active Substance:
  • apraglutide
Invented Name
Not yet available
PIP Number MHRA-101310-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for solution for injection
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of short bowel syndrome
Route(s) of administration
Route(s) of administration:
  • Subcutaneous use
PIP applicant
  • SFL Pharmaceuticals Deutschland GmbH
  • Country Germany
  • Tel +4976215500250
  • Email info@sfl-pharma.eu
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):apraglutide.pdf
Published Date 10/04/2026