KUVAN
As listed in the register: KUVAN
100 mg · tablet
- Prescription only
- Digestion, stomach, diabetes and nutrition
- Active substance
- Sapropterin Dihydrochloride
- Made by
- Biomarin International Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (sapropterin dihydrochloride). It describes the substance, not this exact product.
Sapropterin dihydrochloride is a synthetic form of BH4, the cofactor for the enzyme phenylalanine hydroxylase (PAH).
PAH hydroxylates Phe through an oxidative reaction to form tyrosine.
In vivo endogenous BH4 is converted to quinoid dihydrobiopterin and is metabolized to dihydrobiopterin and biopterin.
Administration of dissolved tablets after a high-fat/high-calorie meal resulted in mean increases in Cmax of 84% and AUC of 87% (dissolved in water).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-06
Safety of the active substance
From the US prescribing label for the same active substance (sapropterin dihydrochloride). It describes the substance, not this exact product.
Most common adverse reactions (≥4%) are: headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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
United States7 matching products
European UnionNo exact match for this strength and form
Spain7 matching products
- KUVAN 100 mg · comprimido
- SAPROPTERINA AUROVITAS 100 mg · comprimido soluble
- SAPROPTERINA DIPHARMA 100 MG · comprimido soluble
- SAPROPTERINA ELC 100 mg · comprimido soluble
- SAPROPTERINA STADA 100 mg · comprimido soluble
- SAPROPTERINA TARBIS 100 mg · comprimido soluble
- SAPROPTERINA TEVA 100 mg · comprimido soluble
Netherlands8 matching products
- Arpetran 100 mg oplosbare tabletten 100 mg · oplosbare tablet
- Kuvan 100 mg oplosbare tabletten 100 mg · tablet
- Sapropterin Dipharma 100 mg 100 mg · oplosbare tablet
- Sapropterine Amarox 100 mg oplosbare tabletten 100 mg · oplosbare tablet
- Sapropterine Aurobindo 100 mg 100 mg · oplosbare tablet
- Sapropterine diHCl CF 100 mg 100 mg · oplosbare tablet
- Sapropterine Sandoz 100 mg 100 mg · oplosbare tablet
- Sapropterine Teva 100 mg 100 mg · oplosbare tablet
SwitzerlandNo exact match for this strength and form
Details
| Made by | Biomarin International Limited |
|---|---|
| Active substance | Sapropterin Dihydrochloride |
| Used in | Digestion, stomach, diabetes and nutrition |
| Strength | 100 mg |
| Form | tablet |
| Classification | A16AX07 · Digestion, stomach, diabetes and nutrition |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02350580 |
| DPD drug code | 83577 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- tablet1 products
- 100 mg
- powder1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.