Medicine guide

Kuvan

·

  • Prescription status not stated
  • Digestion, stomach, diabetes and nutrition
Active substance
Sapropterin
Made by
BioMarin International Limited

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

  • Kuvan 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. Kuvan 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.

From the official label · 2026-09-30 · European Medicines Agency

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

SpainNo exact match for this strength and form

CanadaNo exact match for this strength and form

NetherlandsNo exact match for this strength and form

SwitzerlandNo exact match for this strength and form

Details

Made byBioMarin International Limited
Active substanceSapropterin
Used inDigestion, stomach, diabetes and nutrition
ClassificationA16AX07 · Digestion, stomach, diabetes and nutrition
Authorised on2008-12-02
Last updated by the regulator2026-06-22
EMA product numberEMEA/H/C/000943

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.