Nuceiva
botulinum toxin type a
Table of contents
Overview
Nuceiva is a medicine used to temporarily improve the appearance of vertical frown lines between the eyebrows. It is used in adults less than 65 years of age who have moderate to severe facial lines and in whom those lines are having a significant psychological impact.
Nuceiva contains the active substance botulinum toxin type A.
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List item
Nuceiva : EPAR - Medicine overview (PDF/76.86 KB)
First published: 14/10/2019
EMA/249428/2019 -
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List item
Nuceiva : EPAR - Risk-management-plan summary (PDF/206.79 KB) (updated)
First published: 14/10/2019
Last updated: 19/02/2021
Authorisation details
Product details | |
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Name |
Nuceiva
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Agency product number |
EMEA/H/C/004587
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Active substance |
Botulinum toxin type A
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International non-proprietary name (INN) or common name |
botulinum toxin type a
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Therapeutic area (MeSH) |
Skin Aging
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Anatomical therapeutic chemical (ATC) code |
M03AX01
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Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
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Marketing-authorisation holder |
Evolus Pharma Limited
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
27/09/2019
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Contact address |
Product information
14/01/2021 Nuceiva - EMEA/H/C/004587 - X/0005
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Therapeutic indication
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.