Enspryng
satralizumab
Table of contents
Overview
Enspryng is a medicine used to treat patients aged 12 or above 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 on its own or in combination with immunosuppressive therapy (treatment that reduces the activity of the immune system) in patients with antibodies against a protein called aquaporin-4 (AQP4).
NMOSD is rare, and Enspryng was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 27 June 2016. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3161680.
Enspryng contains the active substance satralizumab.
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Enspryng : EPAR - Medicine overview (PDF/107.66 KB)
First published: 30/06/2021
EMA/298616/2021 -
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Enspryng : EPAR - Risk-management-plan summary (PDF/219.69 KB)
First published: 30/06/2021
Authorisation details
Product details | |
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Name |
Enspryng
|
Agency product number |
EMEA/H/C/004788
|
Active substance |
satralizumab
|
International non-proprietary name (INN) or common name |
satralizumab
|
Therapeutic area (MeSH) |
Neuromyelitis Optica
|
Anatomical therapeutic chemical (ATC) code |
L04AC
|
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
24/06/2021
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
17/03/2023 Enspryng - EMEA/H/C/004788 - N/0008
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
Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.