Botulinum A toxin

Active substance Botulinum A toxin
Domain Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Other neurological disorders
Extended indication Nuceiva is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

Product

Proprietary name Nuceiva
Manufacturer Evolus
Mechanism of action Neurotoxin
Route of administration Intramuscular
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New therapeutical formulation
Submission date August 2017
Expected Registration September 2019
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie april 2019. Geregistreerd per 27/09/2019.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Not found

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.