QUETIAPINE XR 50 MG
QUETIAPINE (QUETIAPINE FUMARATE) : 50 MG · DIN 02417359 · SIVEM PHARMACEUTICALS ULC
Health Canada status: MARKETED
What is QUETIAPINE XR?
QUETIAPINE XR 50 MG contains QUETIAPINE (QUETIAPINE FUMARATE) : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02417359, held by SIVEM PHARMACEUTICALS ULC, supplied as TABLET (EXTENDED-RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 11-Jun-2025. 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 QUETIAPINE XR used for?
Management of schizophrenia; acute manic or depressive episodes in bipolar disorder; symptomatic relief of MDD when other antidepressants have failed.
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 | 02417359 |
|---|---|
| Brand name | QUETIAPINE XR |
| Generic / active ingredient | QUETIAPINE (QUETIAPINE FUMARATE) : 50 MG |
| Manufacturer | SIVEM PHARMACEUTICALS ULC |
| Strength | 50 MG |
| Dosage form | TABLET (EXTENDED-RELEASE) |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | N05AH04 QUETIAPINE |
| AHFS class | 28:16.08.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 11-Jun-2025 |
| Original market date | 2014-01-01 00:00:00 |
How is it administered?
Administer once daily, generally in the evening, with or without food. Tablets must be swallowed whole (not split, chewed, or crushed). Titration varies by indication (Schizophrenia, Bipolar, MDD).
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (refer to section 11 of full monograph). Typical range is 15-30°C.
How is it supplied?
High-density polyethylene (HDPE) bottles of 100 tablets.
Contraindications
Hypersensitivity to quetiapine or to any ingredient in the formulation, including non-medicinal ingredients or components of the container.
Warnings and precautions
Increased mortality in elderly patients with dementia. Risk of Neuroleptic Malignant Syndrome, Tardive Dyskinesia, QT prolongation, orthostatic hypotension, and metabolic changes.
Is QUETIAPINE in shortage in Canada?
A Canadian shortage report is on file for this molecule: Active — reported by JAMP PHARMA CORPORATION (Tier 3 Drug Shortages About & Resources), last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code N05AH04 QUETIAPINE. 93 of 236 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 |
|---|---|---|---|---|---|
| ACH-QUETIAPINE | 100 MG | TABLET (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02387808 |
| ACH-QUETIAPINE | 150 MG | TABLET (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02387816 |
| ACH-QUETIAPINE | 200 MG | TABLET (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02387824 |
| ACH-QUETIAPINE | 25 MG | TABLET (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02387794 |
| ACH-QUETIAPINE | 300 MG | TABLET (IMMEDIATE RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02387832 |
| ACH-QUETIAPINE FUMARATE XR | 150 MG | TABLET (EXTENDED-RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02450879 |
| ACH-QUETIAPINE FUMARATE XR | 200 MG | TABLET (EXTENDED-RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02450887 |
| ACH-QUETIAPINE FUMARATE XR | 300 MG | TABLET (EXTENDED-RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02450895 |
| ACH-QUETIAPINE FUMARATE XR | 400 MG | TABLET (EXTENDED-RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02450909 |
| ACH-QUETIAPINE FUMARATE XR | 50 MG | TABLET (EXTENDED-RELEASE) | ACCORD HEALTHCARE INC | MARKETED | DIN 02450860 |
Who else supplies QUETIAPINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. QUETIAPINE appears in 7122 registered pack listings across 11 markets, published on 8 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.