Botulinum A toxin

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.
Therapeutic value	No judgement
Registration phase	Registered

Product

Active substance	Botulinum A toxin
Domain	Neurological disorders
Reason of inclusion	New medicine (specialité)
Main indication	Neurological disorders other
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.
Proprietary name	Nuceiva
Manufacturer	Evolus
Mechanism of action	Neurotoxin
Route of administration	Intramuscular
Therapeutical formulation	Injection
Budgetting framework	Extramural (GVS)

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 remarks	Positieve CHMP-opinie april 2019. Geregistreerd per 27/09/2019.

Therapeutic value	No judgement

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.