ORFADIN 4 MG
NITISINONE : 4 MG · DIN 02469693 · SWEDISH ORPHAN BIOVITRUM AB (PUBL)
Health Canada status: MARKETED
What is ORFADIN?
ORFADIN 4 MG contains NITISINONE : 4 MG. It is listed in the Health Canada Drug Product Database under DIN 02469693, held by SWEDISH ORPHAN BIOVITRUM AB (PUBL), supplied as SUSPENSION for ORAL administration. Health Canada currently lists it as marketed, status dated 10-Jul-2018. 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 ORFADIN used for?
Orfadin is indicated for the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Treatment with nitisinone should be initiated and supervised by a physician experienced in the treatment of HT-1 patients.
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 | 02469693 |
|---|---|
| Brand name | ORFADIN |
| Generic / active ingredient | NITISINONE : 4 MG |
| Manufacturer | SWEDISH ORPHAN BIOVITRUM AB (PUBL) |
| Strength | 4 MG |
| Dosage form | SUSPENSION |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | A16AX04 NITISINONE |
| AHFS class | 92:92.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 10-Jul-2018 |
| Original market date | 2018-07-10 00:00:00 |
How is it stored and handled?
Store the bottle at room temperature (not above 25°C).
How is it supplied?
Capsules 2 mg, 5 mg, 10 mg and 20 mg. Oral suspension 4 mg/mL.
What can be used instead?
Other Canadian products sharing ATC code A16AX04 NITISINONE. 8 of 12 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 |
|---|---|---|---|---|---|
| MDK-NITISINONE | 10 MG | CAPSULE | MENDELIKABS INC | MARKETED | DIN 02457733 |
| MDK-NITISINONE | 2 MG | CAPSULE | MENDELIKABS INC | MARKETED | DIN 02457717 |
| MDK-NITISINONE | 5 MG | CAPSULE | MENDELIKABS INC | MARKETED | DIN 02457725 |
| ORFADIN | 10 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459728 |
| ORFADIN | 2 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459698 |
| ORFADIN | 20 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459736 |
| ORFADIN | 5 MG | CAPSULE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | MARKETED | DIN 02459701 |
| MDK-NITISINONE | 20 MG | CAPSULE | MENDELIKABS INC | DORMANT | DIN 02470055 |
| NITISINONE TABLETS | 10 MG | TABLET | CYCLE PHARMACEUTICALS LTD. | CANCELLED POST MARKET | DIN 02458632 |
| NITISINONE TABLETS | 2 MG | TABLET | CYCLE PHARMACEUTICALS LTD. | CANCELLED POST MARKET | DIN 02458616 |
Who else supplies NITISINONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NITISINONE appears in 51 registered pack listings across 6 markets, published on 6 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.