Uplizna
inebilizumab
Table of contents
Overview
Uplizna is a medicine used to treat adults with neuromyelitis optica spectrum disorders (NMOSD), inflammatory disorders that affect mainly the optic nerve (which connects the eye to the brain) and the spinal cord. This leads to impaired vision, loss of sensation, loss of bladder control, weakness and paralysis of the arms and legs.
The medicine is used in patients with antibodies against a protein called aquaporin-4 (AQP4).
Uplizna contains the active substance inebilizumab.
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Uplizna : EPAR - Medicine Overview (PDF/119.66 KB)
First published: 19/05/2022
EMA/192406/2022 -
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Uplizna : EPAR - Risk management plan summary (PDF/221.87 KB)
First published: 19/05/2022
Authorisation details
Product details | |
---|---|
Name |
Uplizna
|
Agency product number |
EMEA/H/C/005818
|
Active substance |
Inebilizumab
|
International non-proprietary name (INN) or common name |
inebilizumab
|
Therapeutic area (MeSH) |
Neuromyelitis Optica
|
Anatomical therapeutic chemical (ATC) code |
L04AA
|
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 |
Horizon Therapeutics Ireland DAC
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
25/04/2022
|
Contact address |
Horizon Therapeutics Ireland DAC |
Product information
19/04/2023 Uplizna - EMEA/H/C/005818 - IAIN/0004
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).