Version 2

Miconazole

Medicine

Extended indication Miconazole monotherapy for the treatment of uncomplicated otomycosis in children, adolescents, adults and the elderly.
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Miconazole
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Fungal infections
Extended indication Miconazole monotherapy for the treatment of uncomplicated otomycosis in children, adolescents, adults and the elderly.
Manufacturer Hill
Mechanism of action Unknown
Route of administration Auricular
Therapeutical formulation Unknown
Budgetting framework Extramural (GVS)
Additional remarks Emulsie voor in het oor.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date 2025
Expected Registration January 2026
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Azolen (e.g., clotrimazole, eberconazole, fluconazole en miconazole).
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation De meerwaarde is onduidelijk. Er zijn verschillende azolen voor lokale toediening zoals clotrimazole, eberconazole, fluconazole en miconazole. Een recente meta-analyse concludeerde dat er erg weinig onderbouwing is en weinig verschil tussen de verschillende middelen bestaat (er is nooit een placebo gecontroleerde trial geweest) (2).
References NCT05660382 (1); Lee et al. Cochrane Database Syst Rev. 2021 (2).

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information