Enspryng

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satralizumab

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

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.

This EPAR was last updated on 24/03/2023

Authorisation details

Product details
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
OrphanOrphan

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
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
79639 Grenzach-Wyhlen
Germany

Product information

17/03/2023 Enspryng - EMEA/H/C/004788 - N/0008

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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

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.

Assessment history

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