Extended indication Multiple sclerosis, first line and add-on therapy.
Therapeutic value No judgement
Registration phase Unknown

Product

Active substance Biotin
Domain Neurological disorders
Main indication Multiple sclerosis
Extended indication Multiple sclerosis, first line and add-on therapy.
Proprietary name Qizenday
Manufacturer Medday
Mechanism of action Unknown
Route of administration Unknown
Therapeutical formulation Unknown
Budgetting framework Unknown

Registration

Registration route Unknown
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Orphan drug Unknown
Registration phase Unknown
Additional remarks Registratieaanvraag teruggetrokken in december 2017. 'The company stated that the withdrawal is based on the CHMP’s opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.'

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

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