OPSYNVI 40 MG
TADALAFIL : 40 MG MACITENTAN : 10 MG · DIN 02521083 · JANSSEN INC
Health Canada status: MARKETED
What is OPSYNVI?
OPSYNVI 40 MG contains TADALAFIL : 40 MG MACITENTAN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02521083, held by JANSSEN INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 25-Nov-2021. 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 OPSYNVI used for?
OPSYNVI® (macitentan and tadalafil), is indicated for the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease. OPSYNVI® should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.
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 | 02521083 |
|---|---|
| Brand name | OPSYNVI |
| Generic / active ingredient | TADALAFIL : 40 MG MACITENTAN : 10 MG |
| Manufacturer | JANSSEN INC |
| Strength | 40 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C02KX54 MACITENTAN AND TADALAFIL |
| AHFS class | 48:48.12 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 25-Nov-2021 |
| Original market date | 2021-11-25 00:00:00 |
How is it stored and handled?
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How is it supplied?
30 count film-coated tablets in high-density polyethylene bottles
Who else supplies MACITENTAN AND TADALAFIL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MACITENTAN AND TADALAFIL appears in 34 registered pack listings across 13 markets, published on 10 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.