KUVAN 100 MG
SAPROPTERIN DIHYDROCHLORIDE : 100 MG · DIN 02482207 · BIOMARIN INTERNATIONAL LIMITED
Health Canada status: MARKETED
What is KUVAN?
KUVAN 100 MG contains SAPROPTERIN DIHYDROCHLORIDE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02482207, held by BIOMARIN INTERNATIONAL LIMITED, supplied as POWDER for ORAL administration. Health Canada currently lists it as marketed, status dated 05-Dec-2019. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is KUVAN used for?
Kuvan® (sapropterin dihydrochloride tablets and powder for oral solution) is indicated in conjunction with a phenylalanine (Phe) - restricted diet for the reduction of blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin - (BH4) - responsive Phenylketonuria (PKU).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02482207 |
|---|---|
| Brand name | KUVAN |
| Generic / active ingredient | SAPROPTERIN DIHYDROCHLORIDE : 100 MG |
| Manufacturer | BIOMARIN INTERNATIONAL LIMITED |
| Strength | 100 MG |
| Dosage form | POWDER |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A16AX07 SAPROPTERIN |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 05-Dec-2019 |
How is it stored and handled?
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How is it supplied?
Each bottle contains 120 tablets. Each carton contains 30 unit dose sachets.
What can be used instead?
Other Canadian products sharing ATC code A16AX07 SAPROPTERIN. 5 of 7 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| KUVAN | 100 MG | TABLET | BIOMARIN INTERNATIONAL LIMITED | MARKETED | DIN 02350580 |
| REDDY-SAPROPTERIN | 100 MG | POWDER FOR SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | DIN 02534533 |
| REDDY-SAPROPTERIN | 500 MG | POWDER FOR SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | DIN 02535610 |
| REDDY-SAPROPTERIN | 500 MG | POWDER FOR SOLUTION | DR REDDY'S LABORATORIES LTD | MARKETED | DIN NEW-1776 |
| KUVAN | 500 MG | POWDER | BIOMARIN INTERNATIONAL LIMITED | CANCELLED POST MARKET | DIN 02482215 |
| TEVA-SAPROPTERIN | 100 MG | TABLET | TEVA CANADA LIMITED | APPROVED | DIN 02547481 |
Who else supplies SAPROPTERIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. SAPROPTERIN appears in 27 registered pack listings across 7 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.