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.

1. Product

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

2. 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.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Not found

4. Expected patient volume per year

There is currently nothing known about the expected patient volume.

5. Expected cost per patient per year

There is currently nothing known about the expected cost.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.