Aspaveli
pegcetacoplan
Table of contents
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.
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Aspaveli : EPAR - Medicine overview (PDF/123.29 KB)
First published: 16/12/2021
EMA/603278/2021 -
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Aspaveli : EPAR - Risk-management-plan summary (PDF/214.53 KB)
First published: 16/12/2021
Last updated: 06/09/2022
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 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. |
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 |
Swedish Orphan Biovitrum AB (publ)
|
Revision |
3
|
Date of issue of marketing authorisation valid throughout the European Union |
13/12/2021
|
Contact address |
SE-112 76 Stockholm |
Product information
19/05/2022 Aspaveli - EMEA/H/C/005553 - II/0002
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
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.