REVATIO 0.8 MG — DIN 02341611
SILDENAFIL (SILDENAFIL CITRATE) : 0.8 MG · BGP PHARMA ULC · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is REVATIO?
REVATIO 0.8 MG contains SILDENAFIL (SILDENAFIL CITRATE) : 0.8 MG. It is listed in the Health Canada Drug Product Database under DIN 02341611, held by BGP PHARMA ULC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 11-Sep-2023. 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 REVATIO used for?
Treatment of primary pulmonary arterial hypertension (PPH) or PAH secondary to connective tissue disease (CTD) in adults (WHO class II/III). Injection for patients temporarily unable to take oral.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Antihypertensives For Pulmonary Arterial Hypertension in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
7 holders have a Canadian DIN containing Antihypertensives For Pulmonary Arterial Hypertension, across 8 DINs, of which 5 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| BGP PHARMA ULC | 2 | 2 | REVATIO | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | JAMP-SILDENAFIL R | Sourceable in Canada |
| PHARMASCIENCE INC | 1 | 1 | PMS-SILDENAFIL R | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 1 | TEVA-SILDENAFIL R | Sourceable in Canada |
| APOTEX INC | 1 | 0 | APO-SILDENAFIL R | No marketed DIN |
| MELIAPHARM INC | 1 | 0 | FINASTERIDE | No marketed DIN |
| METHAPHARM INC | 1 | 0 | SILDENAFIL R | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
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 | 0.8 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Not explicitly detailed in provided text (refers to Dosage Forms, Composition and Packaging section). |
| Storage | Not explicitly detailed in provided text (refers to Special Handling Instructions/Packaging section). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Antihypertensives For Pulmonary Arterial Hypertension |
|---|---|
| ATC code | C02KX |
| AHFS class | 84:04.92 |
| 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) | 02341611 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2341611 |
| Brand name | REVATIO |
| Generic / active ingredient | SILDENAFIL (SILDENAFIL CITRATE) : 0.8 MG |
| Market authorization holder | BGP PHARMA ULC |
| Health Canada schedule | Prescription |
| ATC code | C02KX |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C02KX |
| Current status | MARKETED |
| Status date | 11-Sep-2023 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Oral: 20 mg three times a day (t.i.d.). Injection: 10 mg (12.5 mL) three times a day administered as an intravenous bolus injection.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Nitrate therapy; hypersensitivity; previous NAION; potent CYP3A4 inhibitors; sickle cell anaemia; severe hepatic impairment; recent stroke/MI; unstable angina; severe hypotension; riociguat.
Warnings and precautions
Not recommended for pulmonary veno-occlusive disease. Risk of NAION (vision loss). Sudden hearing loss. Potential for priapism. Caution with bleeding disorders or alpha-blockers.
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.
1 · Same molecule, other Canadian presentations
5 of 8 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| JAMP-SILDENAFIL R | 20 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02469669 |
| PMS-SILDENAFIL R | 20 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02412179 |
| REVATIO | 20 MG | TABLET | BGP PHARMA ULC | MARKETED | 02279401 |
| TEVA-SILDENAFIL R | 20 MG | TABLET | TEVA CANADA LIMITED | MARKETED | 02319500 |
| APO-SILDENAFIL R | 20 MG | TABLET | APOTEX INC | DORMANT | 02418118 |
| FINASTERIDE | 5 MG | TABLET | MELIAPHARM INC | CANCELLED POST MARKET | 02348888 |
| SILDENAFIL R | 20 MG | TABLET | METHAPHARM INC | APPROVED | 02450968 |
2 · Same class — other molecules in ATC C02KX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Riociguat | ADEMPAS · SANDOZ RIOCIGUAT | 10 | 10 | Yes |
| Bosentan | ACCEL-BOSENTAN · ACT BOSENTAN · ALEMBIC-BOSENTAN · APO-BOSENTAN · +12 more | 32 | 6 | Yes |
| Antihypertensives For Pulmonary Arterial Hypertension | APO-SILDENAFIL R · FINASTERIDE · JAMP-SILDENAFIL R · PMS-SILDENAFIL R · +3 more | 8 | 5 | Yes |
| Ambrisentan | APO-AMBRISENTAN · AURO-AMBRISENTAN · JAMP AMBRISENTAN · M-AMBRISENTAN · +4 more | 16 | 4 | Yes |
| Sotatercept | WINREVAIR | 4 | 2 | Yes |
| Macitentan And Tadalafil | OPSYNVI | 1 | 1 | Yes |
| Macitentan | OPSUMIT | 1 | 1 | Yes |
| Sitaxentan | THELIN | 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 C02K
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| C02KN | Aprocitentan | 2 | 0 |
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.
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.