VOLIBRIS 10 MG
AMBRISENTAN : 10 MG · DIN 02307073 · GLAXOSMITHKLINE INC
Health Canada status: MARKETED
What is VOLIBRIS?
VOLIBRIS 10 MG contains AMBRISENTAN : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02307073, held by GLAXOSMITHKLINE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 24-Jun-2008. 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 VOLIBRIS used for?
Treatment of idiopathic pulmonary arterial hypertension (IPAH) and PAH associated with connective tissue disease (WHO class II or III); initiation therapy in combination with tadalafil.
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 | 02307073 |
|---|---|
| Brand name | VOLIBRIS |
| Generic / active ingredient | AMBRISENTAN : 10 MG |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 10 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C02KX02 AMBRISENTAN |
| AHFS class | 48:48.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 24-Jun-2008 |
| Original market date | 2008-06-24 00:00:00 |
How is it administered?
Initiate at 5 mg once daily. May increase to 10 mg once daily. In combination with tadalafil, uptitrate both drugs over 8 weeks. Max dose 10 mg. Limit to 5 mg when used with cyclosporine A.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (standard section 11 header present but content truncated).
How is it supplied?
Blister packs of 30 tablets.
Contraindications
Hypersensitivity; Pregnancy; Breastfeeding; Severe hepatic impairment; Baseline AST/ALT >3x ULN; Idiopathic pulmonary fibrosis (IPF).
Warnings and precautions
Fluid retention/peripheral edema; decreased hemoglobin/hematocrit (anemia); potential hepatotoxicity; pulmonary veno-occlusive disease risk; potential effect on male fertility.
What can be used instead?
Other Canadian products sharing ATC code C02KX02 AMBRISENTAN. 4 of 16 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 |
|---|---|---|---|---|---|
| APO-AMBRISENTAN | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02475383 |
| APO-AMBRISENTAN | 5 MG | TABLET | APOTEX INC | MARKETED | DIN 02475375 |
| VOLIBRIS | 5 MG | TABLET | GLAXOSMITHKLINE INC | MARKETED | DIN 02307065 |
| AURO-AMBRISENTAN | 10 MG | TABLET | AURO PHARMA INC | APPROVED | DIN 02527103 |
| AURO-AMBRISENTAN | 5 MG | TABLET | AURO PHARMA INC | APPROVED | DIN 02527081 |
| JAMP AMBRISENTAN | 10 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | DIN 02521946 |
| JAMP AMBRISENTAN | 5 MG | TABLET | JAMP PHARMA CORPORATION | DORMANT | DIN 02521938 |
| M-AMBRISENTAN | 10 MG | TABLET | MANTRA PHARMA INC | APPROVED | DIN 02554097 |
| M-AMBRISENTAN | 5 MG | TABLET | MANTRA PHARMA INC | APPROVED | DIN 02554089 |
| SANDOZ AMBRISENTAN | 10 MG | TABLET | SANDOZ CANADA INCORPORATED | CANCELLED PRE MARKET | DIN 02525313 |
Who else supplies AMBRISENTAN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. AMBRISENTAN appears in 171 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.