HARVONI 400 MG — DIN 02432226
SOFOSBUVIR : 400 MG LEDIPASVIR : 90 MG · GILEAD SCIENCES CANADA INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is HARVONI?
HARVONI 400 MG contains SOFOSBUVIR : 400 MG LEDIPASVIR : 90 MG. It is listed in the Health Canada Drug Product Database under DIN 02432226, held by GILEAD SCIENCES CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 16-Oct-2014. 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 HARVONI used for?
Treatment of chronic hepatitis C virus (CHC) infection in adults and pediatric patients ≥ 12 years of age (Genotype 1). Also for Genotypes 2, 3, 4, 5, 6 in specific adult populations.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Sofosbuvir And Ledipasvir cost around the world?
Sofosbuvir And Ledipasvir is listed on 15 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Norway | max AUP (pharmacy retail) | 3 | 8 | NOK███.██ |
| Brazil | preco fabrica (ex-factory ceiling) | 4 | 7 | BRL███.██ |
| Saudi Arabia | public | 7 | 7 | SAR███.██ |
| Australia | ex-manufacturer | 2 | 6 | AUD███.██ |
| Luxembourg | reimbursement | 4 | 4 | EUR███.██ |
| United Arab Emirates | public | 2 | 2 | AED███.██ |
| Czechia | max producer price (ex-factory) | 2 | 2 | CZK███.██ |
| Iceland | max wholesale | 2 | 2 | ISK███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 1 | 1 | EUR███.██ |
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
| Greece | producer price (ex-factory) | 1 | 1 | EUR███.██ |
| Hungary | producer price (ex-factory) | 1 | 1 | HUF███.██ |
| Romania | max producer price | 1 | 1 | RON███.██ |
| Slovakia | categorised final price | 1 | 1 | EUR███.██ |
46 pack listings across 34 brand entries and 13 price bases, refreshed 08 Sep 2026. Ranges span every Sofosbuvir And Ledipasvir pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 400 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Bottles of 28 tablets with a silica gel desiccant, polyester coil, and child-resistant closure. |
| Storage | Store at 15-30°C (implied by standard practice, though specific range not explicitly in text provided, section 11 is listed in TOC). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Sofosbuvir And Ledipasvir |
|---|---|
| ATC code | J05AP51 |
| AHFS class | 08:18.40.24 ; 08:18.40.16 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02432226 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2432226 |
| Brand name | HARVONI |
| Generic / active ingredient | SOFOSBUVIR : 400 MG LEDIPASVIR : 90 MG |
| Market authorization holder | GILEAD SCIENCES CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | J05AP51 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J05AP |
| Current status | MARKETED |
| Status date | 16-Oct-2014 |
| Original market date | 2014-10-16 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
One tablet (90 mg/400 mg) orally once daily with or without food. Duration varies (8, 12, or 24 weeks) based on genotype, treatment history, and cirrhosis status.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to any component. When used with ribavirin (RBV), RBV contraindications apply (including pregnancy and male partners of pregnant women).
Warnings and precautions
Potential for Hepatitis B Virus (HBV) reactivation; screen all patients before treatment. Serious symptomatic bradycardia when coadministered with amiodarone.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC J05AP
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Glecaprevir And Pibrentasvir | MAVIRET | 2 | 2 | Yes |
| Ribavirin | IBAVYR · MODERIBA · VIRAZOLE · VIRAZOLE PWS 6GM/VIAL | 8 | 1 | Yes |
| Sofosbuvir | SOVALDI | 1 | 1 | Yes |
| Sofosbuvir And Ledipasvir | HARVONI | 1 | 1 | Yes |
| Sofosbuvir, Velpatasvir And Voxilaprevir | VOSEVI | 1 | 1 | Yes |
| Daclatasvir | DAKLINZA | 2 | 0 | Not in Canada |
| Asunaprevir | SUNVEPRA | 1 | 0 | Not in Canada |
| Telaprevir | INCIVEK | 1 | 0 | Not in Canada |
| Boceprevir | VICTRELIS | 1 | 0 | Not in Canada |
| Dasabuvir, Ombitasvir, Paritaprevir And Ritonavir | HOLKIRA PAK | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC J05A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J05AB | Acyclovir · Brincidofovir · Cidofovir · Famciclovir · Ganciclovir · +3 more | 143 | 55 |
| J05AR | Antivirals For Treatment Of Hiv Infections, Combinations · Atanazavir And Cobicistat · Darunavir And Cobicistat · Dolutegravir And Rilpivirine · Emtricitabine And Tenofovir Alafenamide · +16 more | 56 | 39 |
| J05AF | Abacavir · Adefovir Dipivoxil · Didanosine · Emtricitabine · Entecavir · +7 more | 71 | 39 |
| J05AH | Neuraminidase Inhibitors · Oseltamivir · Zanamivir | 33 | 16 |
| J05AX | Baloxavir Marboxil · Bulevirtide · Enfuvirtide · Fostemsavir · Inosine Pranobex · +5 more | 19 | 14 |
| J05AE | Amprenavir · Atazanavir · Darunavir · Fosamprenavir · Indinavir · +5 more | 75 | 14 |
| J05AG | Delavirdine · Doravirine · Efavirenz · Etravirine · Nevirapine · +1 more | 22 | 10 |
| J05AJ | Cabotegravir · Dolutegravir · Elvitegravir · Raltegravir | 12 | 6 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is HARVONI called?
The same molecule, Sofosbuvir And Ledipasvir, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Epclusa | Latin | Australia, Brazil, Czechia, Norway, South Africa |
| Vosevi | Latin | Australia, Brazil, Czechia, Iceland, Norway |
| SOFOSBUVIR | Latin | Brazil |
| Sovaldi | Latin | Brazil, Iceland, Norway |
| Grateziano | Latin | Saudi Arabia |
| NUCLEOBUVIR | Latin | Bahrain |
| Sovaldi ® | Latin | United Arab Emirates |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.