Palynziq
pegvaliase
Table of contents
Overview
Palynziq is a medicine that is used to treat phenylketonuria (PKU) in adults and adolescents from 16 years of age.
Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system. Palynziq is used in patients whose blood levels of phenylalanine have not been adequately controlled with other treatments.
Palynziq was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 28 January 2010.
Further information on the orphan designation can be found EU/3/09/708.
Palynziq contains the active substance pegvaliase.
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Palynziq : EPAR - Medicine overview (PDF/78.4 KB)
First published: 29/05/2019 -
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Palynziq : EPAR - Risk-management-plan summary (PDF/829.02 KB)
First published: 29/05/2019
Last updated: 10/06/2022
Authorisation details
Product details | |
---|---|
Name |
Palynziq
|
Agency product number |
EMEA/H/C/004744
|
Active substance |
Pegvaliase
|
International non-proprietary name (INN) or common name |
pegvaliase
|
Therapeutic area (MeSH) |
Phenylketonurias
|
Anatomical therapeutic chemical (ATC) code |
A16AB19
|
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 |
BioMarin International Limited
|
Revision |
7
|
Date of issue of marketing authorisation valid throughout the European Union |
03/05/2019
|
Contact address |
Shanbally |
Product information
24/03/2023 Palynziq - EMEA/H/C/004744 - PSUSA/00010761/202205
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 alimentary tract and metabolism products
Therapeutic indication
Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.