Pyrukynd
mitapivat
Table of contents
Overview
Pyrukynd is a medicine used to treat adults with pyruvate kinase deficiency (PKD), an inherited disease that causes red blood cells to break down faster than normal.
PKD is rare, and Pyrukynd was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 April 2020. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2270.
Pyrukynd contains the active substance mitapivat.
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List item
Pyrukynd - EPAR - Medicine Overview (PDF/119.47 KB)
First published: 05/12/2022
EMA/792190/2022 -
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Pyrukynd : EPAR - Risk Management Plan (PDF/1.29 MB)
First published: 05/12/2022
Authorisation details
Product details | |
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Name |
Pyrukynd
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Agency product number |
EMEA/H/C/005540
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Active substance |
mitapivat sulfate
|
International non-proprietary name (INN) or common name |
mitapivat
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
B06AX04
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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 |
Agios Netherlands B.V.
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Date of issue of marketing authorisation valid throughout the European Union |
09/11/2022
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Contact address |
Zuidplein 36 |
Product information
Pyrukynd - EMEA/H/C/005540 -
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
Other hematological agents
Therapeutic indication
Pyrukynd is indicated for the treatment of pyruvate kinase deficiency (PK deficiency) in adult patients (see section 4.4).