Sapropterin Dipharma

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sapropterin

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

Overview

Sapropterin Dipharma is a medicine that is used to treat high blood levels of phenylalanine in adults and children of all ages with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.

Patients with these disorders cannot process the amino acid phenylalanine from dietary protein. As a result, phenylalanine builds up in the blood to abnormally high levels, causing problems in the nervous system.

Sapropterin Dipharma contains the active substance sapropterin and is a ‘generic medicine’. This means that Sapropterin Dipharma contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Kuvan. For more information on generic medicines, see the question-and-answer document here.

This EPAR was last updated on 17/11/2022

Authorisation details

Product details
Name
Sapropterin Dipharma
Agency product number
EMEA/H/C/005646
Active substance
Sapropterin dihydrochloride
International non-proprietary name (INN) or common name
sapropterin
Therapeutic area (MeSH)
Phenylketonurias
Anatomical therapeutic chemical (ATC) code
A16AX07
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Dipharma B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
16/02/2022
Contact address

Prins Bernhardplein 200
1097 JB Amsterdam
Netherlands

Product information

17/11/2022 Sapropterin Dipharma - EMEA/H/C/005646 - IB/0007/G

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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

Other alimentary tract and metabolism products

Therapeutic indication

Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment.

Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.

Assessment history

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