Extended indication

Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with

Therapeutic value

No estimate possible yet

Registration phase

Positive CHMP opinion

Product

Active substance

Fezolinetant

Domain

Metabolism and Endocrinology

Reason of inclusion

New medicine (specialité)

Main indication

Metabolic diseases

Extended indication

Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Proprietary name

unknown

Manufacturer

Astellas

Portfolio holder

Astellas

Mechanism of action

Receptor antagonist

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Extramural (GVS)

Additional remarks
Neurokinine-3-receptor antagonist

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

August 2022

Expected Registration

December 2023

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional remarks
Positieve CHMP-opinie oktober 2023

Therapeutic value

Current treatment options

De standaard geneesmiddelbehandeling voor vasomotorische symptomen in de menopauze is hormoontherapie met een combinatie van oestrogeen en progesteron, of oestrogeen alleen.

Therapeutic value

No estimate possible yet

Frequency of administration

1 times a day

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Additional remarks
De lijstprijs zal eind 2023 bekend zijn.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension

No

References
adisinsght

Other information

There is currently no futher information available.