Sapropterin Dipharma
- Prescription status not stated
- Digestion, stomach, diabetes and nutrition
- Active substance
- Sapropterin
- Made by
- Dipharma Arzneimittel GmbH
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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.
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 by | Dipharma Arzneimittel GmbH |
|---|---|
| Active substance | Sapropterin |
| Used in | Digestion, stomach, diabetes and nutrition |
| Classification | A16AX07 · Digestion, stomach, diabetes and nutrition |
| Generic | Yes — a generic medicine, according to the register |
| Authorised on | 2022-02-16 |
| Last updated by the regulator | 2026-05-18 |
| EMA product number | EMEA/H/C/005646 |
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.