RENFLEXIS 100 MG
INFLIXIMAB : 100 MG · DIN 02470373 · SAMSUNG BIOEPIS CO., LTD
Health Canada status: MARKETED
What is RENFLEXIS?
RENFLEXIS 100 MG contains INFLIXIMAB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02470373, held by SAMSUNG BIOEPIS CO., LTD, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 22-Mar-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 RENFLEXIS used for?
RENFLEXIS (Infliximab for Injection) is indicated for use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical function in adult patients with moderately to severely active rheumatoid arthritis. It is also indicated for the reduction of signs and symptoms and improvement in physical function in patients with active ankylosing spondylitis who have responded inadequately, or are intolerant to, conventional therapies. Additionally, it is used for reduction of signs and symptoms, induction and maintenance of clinical remission and mucosal healing and reduction of corticosteroid use in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to a corticosteroid and/or aminosalicylate.
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 | 02470373 |
|---|---|
| Brand name | RENFLEXIS |
| Generic / active ingredient | INFLIXIMAB : 100 MG |
| Manufacturer | SAMSUNG BIOEPIS CO., LTD |
| Strength | 100 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Schedule D |
| ATC code | L04AB02 INFLIXIMAB |
| AHFS class | 90:24.16.92 |
| Biosimilar | Yes |
| Health Canada status | MARKETED |
| Status date | 22-Mar-2018 |
| Original market date | 2018-03-22 00:00:00 |
How is it stored and handled?
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How is it supplied?
individually boxed single-use 20 mL vials in the following strength: 100 mg infliximab for injection.
What can be used instead?
Other Canadian products sharing ATC code L04AB02 INFLIXIMAB. 6 of 9 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 |
|---|---|---|---|---|---|
| AVSOLA | 100 MG | POWDER FOR SOLUTION | AMGEN CANADA INC | MARKETED | DIN 02496933 |
| IXIFI | 100 MG | POWDER FOR SOLUTION | PFIZER CANADA ULC | MARKETED | DIN 02523191 |
| REMDANTRY | 100 MG | POWDER FOR SOLUTION | CELLTRION INC. | MARKETED | DIN 02419475 |
| REMICADE | 100 MG | POWDER FOR SOLUTION | JANSSEN INC | MARKETED | DIN 02244016 |
| REMSIMA SC | 120 MG | SOLUTION ; KIT | CELLTRION INC. | MARKETED | DIN 02511584 |
| OMVYENCE | 100 MG | POWDER FOR SOLUTION | JANSSEN INC | APPROVED | DIN 02510308 |
| REMSIMA | 100 MG | POWDER FOR SOLUTION | CELLTRION INC. | CANCELLED POST MARKET | DIN 02419483 |
| REMSIMA SC | 120 MG | KIT ; SOLUTION | CELLTRION INC. | APPROVED | DIN 02511576 |
Who else supplies INFLIXIMAB worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. INFLIXIMAB appears in 1982 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.