SALOFALK 4 G / 60 G
MESALAZINE : 4 G / 60 G · DIN 02112809 · ABBVIE CORPORATION
Health Canada status: MARKETED
What is SALOFALK?
SALOFALK 4 G / 60 G contains MESALAZINE : 4 G / 60 G. It is listed in the Health Canada Drug Product Database under DIN 02112809, held by ABBVIE CORPORATION, supplied as SUSPENSION for RECTAL administration. Health Canada currently lists it as marketed, status dated 12-Jun-2024. 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 SALOFALK used for?
Management of distal ulcerative colitis (DUC) extending to the splenic flexure; adjunctive therapy in extensive disease; prevention of relapse in DUC.
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 | 02112809 |
|---|---|
| Brand name | SALOFALK |
| Generic / active ingredient | MESALAZINE : 4 G / 60 G |
| Manufacturer | ABBVIE CORPORATION |
| Strength | 4 G / 60 G |
| Dosage form | SUSPENSION |
| Route of administration | RECTAL |
| Schedule | Prescription |
| ATC code | A07EC02 MESALAZINE |
| AHFS class | 56:36.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 12-Jun-2024 |
| Original market date | 1995-12-31 00:00:00 |
How is it administered?
Acute: 4 g/60 g daily at bedtime. Relapse prevention: 2 g/60 g daily at bedtime. Tapering recommended for discontinuation. Retain during rest period for best results.
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?
Cartons containing 7 bottles. Each bottle is a thin-walled collapsible unit with a pre-lubricated nozzle and one-way valve.
Contraindications
Hypersensitivity to mesalamine, salicylates, or ingredients; severe renal/hepatic impairment; gastric/duodenal ulcer; urinary tract obstructions; infants under two years of age.
Warnings and precautions
Acute intolerance syndrome (cramping, pain, bloody diarrhea); renal impairment/interstitial nephritis; severe cutaneous reactions (SJS, TEN, DRESS); photosensitivity; myocarditis/pericarditis.
What can be used instead?
Other Canadian products sharing ATC code A07EC02 MESALAZINE. 18 of 29 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 |
|---|---|---|---|---|---|
| MEZAVANT | 1.2 G | TABLET (DELAYED AND EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | DIN 02297558 |
| MEZERA | 1 G | SUPPOSITORY | AVIR PHARMA INC. | MARKETED | DIN 02474018 |
| MEZERA | 1 G | TABLET (DELAYED-RELEASE) | AVIR PHARMA INC. | MARKETED | DIN 02545012 |
| MEZERA | 1 G | FOAM | AVIR PHARMA INC. | MARKETED | DIN 02474026 |
| MEZERA | 500 MG | TABLET (DELAYED-RELEASE) | AVIR PHARMA INC. | MARKETED | DIN 02524481 |
| OCTASA | 1600 MG | TABLET (DELAYED-RELEASE) | TILLOTTS PHARMA AG | MARKETED | DIN 02529610 |
| OCTASA | 800 MG | TABLET (DELAYED-RELEASE) | TILLOTTS PHARMA AG | MARKETED | DIN 02465752 |
| PENTASA | 1 G | SUPPOSITORY | FERRING INC | MARKETED | DIN 02153564 |
| PENTASA | 1 G | TABLET (EXTENDED-RELEASE) | FERRING INC | MARKETED | DIN 02399466 |
| PENTASA | 1 G / 100 ML | SUSPENSION | FERRING INC | MARKETED | DIN 02153521 |
Who else supplies MESALAZINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MESALAZINE appears in 884 registered pack listings across 11 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.