Aspaveli

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pegcetacoplan

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

Overview

Aspaveli is a medicine to treat adults with paroxysmal nocturnal haemoglobinuria (PNH), a condition in which there is excessive breakdown of red blood cells (haemolysis), leading to large amounts of haemoglobin (the protein in red blood cells that carries oxygen around the body) being released into the urine. Aspaveli is used in patients who continue to have anaemia (low levels of red blood cells) despite treatment with a type of medicine called a C5 inhibitor for at least 3 months.

Paroxysmal nocturnal haemoglobinuria is rare, and Aspaveli was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 May 2017.

Aspaveli contains the active substance pegcetacoplan.

This EPAR was last updated on 21/02/2022

Authorisation details

Product details
Name
Aspaveli
Agency product number
EMEA/H/C/005553
Active substance
Pegcetacoplan
International non-proprietary name (INN) or common name
pegcetacoplan
Therapeutic area (MeSH)
Hemoglobinuria, Paroxysmal
Anatomical therapeutic chemical (ATC) code
L04
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.

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
Swedish Orphan Biovitrum AB (publ)
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
13/12/2021
Contact address

SE-112 76 Stockholm
Sweden

Product information

19/05/2022 Aspaveli - EMEA/H/C/005553 - II/0002

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

Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.

Assessment history

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