Uplizna

RSS

inebilizumab

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 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 monitoringAdditional 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
Marketing-authorisation holder
Viela Bio
Date of issue of marketing authorisation valid throughout the European Union
25/04/2022
Contact address

Schiphol Boulevard 359
1118 BJ Schiphol
Netherlands

Product information

Uplizna - EMEA/H/C/005818 -

Product information documents contain:

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).

Assessment history

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