Extended indication Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients.
Therapeutic value No estimate possible yet
Registration phase Positive CHMP opinion

Product

Active substance Methotrexaat
Domain Chronic immune diseases
Reason of inclusion Indication extension IND
Main indication Skin diseases
Extended indication Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients.
Proprietary name Nordimet
Manufacturer Nordic Pharma
Mechanism of action Unknown
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date November 2022
Expected Registration December 2023
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in september 2023.

Therapeutic value

Therapeutic value No estimate possible yet

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