MHRA-102399-PIP01-26

Key Facts

Active Substance
Active Substance:
  • TACROLIMUS MONOHYDRATE
Invented Name
Tacrolimus 4 mg/vial Powder and solvent for rectal suspension
PIP Number MHRA-102399-PIP01-26
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for rectal suspension
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of ulcerative colitis
Route(s) of administration
Route(s) of administration:
  • Rectal use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):TACROLIMUS MONOHYDRATE.pdf
Published Date 06/07/2026