BACLOFEN INJECTION 0.05 MG / 1 ML
BACLOFEN : 0.05 MG / 1 ML · DIN 02413620 · STERIMAX INC
Health Canada status: MARKETED
What is BACLOFEN INJECTION?
BACLOFEN INJECTION 0.05 MG / 1 ML contains BACLOFEN : 0.05 MG / 1 ML. It is listed in the Health Canada Drug Product Database under DIN 02413620, held by STERIMAX INC, supplied as SOLUTION for INTRATHECAL administration. Health Canada currently lists it as marketed, status dated 12-Jan-2018. 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 BACLOFEN INJECTION used for?
Baclofen Injection (baclofen injection) is indicated for: • The management of patients with severe spasticity due to spinal cord injury or multiple sclerosis who are unresponsive to oral baclofen or who experience unacceptable side effects at effective oral doses . Baclofen Injection therapy may be considered as an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion, patients must demonstrate a positive clinical response to a baclofen injection screening trial (see 4.2 Recommended Dose and Dosage Adjustment). Baclofen injection has been used in patients with other spasticity of cerebral origin, e.g. spasticity following hypoxic encephalopathy, head injury, or stroke; however, clinical experience is limited .
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 | 02413620 |
|---|---|
| Brand name | BACLOFEN INJECTION |
| Generic / active ingredient | BACLOFEN : 0.05 MG / 1 ML |
| Manufacturer | STERIMAX INC |
| Strength | 0.05 MG / 1 ML |
| Dosage form | SOLUTION |
| Route of administration | INTRATHECAL |
| Schedule | Prescription |
| ATC code | M03BX01 BACLOFEN |
| AHFS class | 28:12.92 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 12-Jan-2018 |
| Original market date | 2013-11-21 00:00:00 |
How is it stored and handled?
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How is it supplied?
Baclofen Injection 0.05 mg/mL and 2 mg/mL are provided in cartons of 5 ampoules. Baclofen Injection 0.5 mg/mL is provided in cartons of 1 ampoule
Is BACLOFEN in shortage in Canada?
A Canadian shortage report is on file for this molecule: Discontinued — reported by AVIR PHARMA INC., 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 M03BX01 BACLOFEN. 23 of 59 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-BACLOFEN | 10 MG | TABLET | APOTEX INC | MARKETED | DIN 02139332 |
| APO-BACLOFEN | 20 MG | TABLET | APOTEX INC | MARKETED | DIN 02139391 |
| BACLOFEN | 10 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02544660 |
| BACLOFEN | 10 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02287021 |
| BACLOFEN | 20 MG | TABLET | SANIS HEALTH INC | MARKETED | DIN 02287048 |
| BACLOFEN | 20 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | DIN 02544679 |
| BACLOFEN INJECTION | 10 MG / 20 ML | SOLUTION | STERIMAX INC | MARKETED | DIN 02413639 |
| BACLOFEN INJECTION | 10 MG / 5 ML | SOLUTION | STERIMAX INC | MARKETED | DIN 02413647 |
| BACLOFEN INJECTION | 2 MG | SOLUTION | HIKMA CANADA LIMITED | MARKETED | DIN 02457075 |
| BACLOFEN INJECTION USP | 2 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02553341 |
Who else supplies BACLOFEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. BACLOFEN appears in 174 registered pack listings across 12 markets, published on 9 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.