MHRA-101800-PIP01-25

Key Facts

Active Substance
  • OMEPRAZOLE MAGNESIUM
  • AMOXICILLIN TRIHYDRATE
  • RIFABUTIN
Invented Name
  • Talicia
  • Talicia
  • Talicia
PIP Number MHRA-101800-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Gastroenterology-Hepatology
Conditions / Indications
Conditions / Indications:
  • Treatment of Helicobacter spp. infection
Route(s) of administration
Route(s) of administration:
  • Oral 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):OMEPRAZOLE MAGNESIUMAMOXICILLIN TRIHYDRATERIFABUTIN.pdf
Published Date 14/07/2025