Extended indication Eradicatie van Helicobacter pylori bij een ulcus pepticum.
Therapeutic value No judgement
Total cost 1,703,955.00
Registration phase Clinical trials

Product

Active substance Amoxicilline / omeprazol / rifabutin
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Bacterial infections
Extended indication Eradicatie van Helicobacter pylori bij een ulcus pepticum.
Proprietary name Talicia
Manufacturer RedHill
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Combinatie van twee antibiotica en een maagzuurremmer.

Registration

Registration route Centralised (EMA)
Particularity New therapeutical formulation
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Betreft alternatief voor Panclamox.
Therapeutic value No judgement

Expected patient volume per year

Patient volume

10,000 - 20,981

Market share is generally not included unless otherwise stated.

References GIP databank
Additional remarks 20.981 gebruikers Panclamox (alternatief) in 2016.

Expected cost per patient per year

Cost 70.00 - 150.00
Additional remarks Beperkte kosten, naar verwachting vergelijkbaar met Panclamox (uitgaande van 7 - 14 dagen, 2x per dag).

Potential total cost per year

Total cost

1,703,955.00

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References SPS

Other information

There is currently no futher information available.