CELLCEPT I.V. 500 MG
MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) : 500 MG · DIN 02240347 · HOFFMANN-LA ROCHE LIMITED
Health Canada status: MARKETED
What is CELLCEPT I.V.?
CELLCEPT I.V. 500 MG contains MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 02240347, held by HOFFMANN-LA ROCHE LIMITED, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 20-Dec-1999. 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 CELLCEPT I.V. used for?
Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Used concomitantly with cyclosporine and corticosteroids.
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 | 02240347 |
|---|---|
| Brand name | CELLCEPT I.V. |
| Generic / active ingredient | MYCOPHENOLATE MOFETIL (MYCOPHENOLATE MOFETIL HYDROCHLORIDE) : 500 MG |
| Manufacturer | HOFFMANN-LA ROCHE LIMITED |
| Strength | 500 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L04AA06 MYCOPHENOLIC ACID |
| AHFS class | 90:28.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 20-Dec-1999 |
| Original market date | 1999-12-20 00:00:00 |
How is it administered?
Adult Renal: 1 g BID (oral/IV). Adult Cardiac/Hepatic: 1.5 g BID oral or 1 g (IV)/1.5 g (oral) BID. Pediatrics: 600 mg/m2 BID. IV must be infused over ≥2 hours. Take oral on empty stomach.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Reconstituted oral suspension: 15-30°C for up to 60 days (do not freeze). Diluted IV solution: 15-30°C, start infusion within 4 hours of reconstitution.
How is it supplied?
Capsules: Blister packs (100s). Tablets: Blister packs (50s). Oral Suspension: 225 mL bottle (165 mL deliverable). IV: 20 mL sterile vials (cartons of 4).
Contraindications
Hypersensitivity to mycophenolate mofetil or acid; CellCept i.v. contraindicated if allergic to Polysorbate 80; pregnancy; women of childbearing potential not using highly effective contraception.
Warnings and precautions
Serious risk of first trimester pregnancy loss and congenital malformations. Increased susceptibility to infection and lymphoma. Monitor for neutropenia. Avoid in Lesch-Nyhan syndrome.
What can be used instead?
Other Canadian products sharing ATC code L04AA06 MYCOPHENOLIC ACID. 24 of 41 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-MYCOPHENOLATE | 250 MG | CAPSULE | ACCORD HEALTHCARE INC | MARKETED | DIN 02383780 |
| ACH-MYCOPHENOLATE | 500 MG | TABLET | ACCORD HEALTHCARE INC | MARKETED | DIN 02378574 |
| APO-MYCOPHENOLIC ACID | 180 MG | TABLET (ENTERIC-COATED) | APOTEX INC | MARKETED | DIN 02372738 |
| APO-MYCOPHENOLIC ACID | 360 MG | TABLET (ENTERIC-COATED) | APOTEX INC | MARKETED | DIN 02372746 |
| CELLCEPT | 200 MG | POWDER FOR SUSPENSION | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02242145 |
| CELLCEPT | 250 MG | CAPSULE | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02192748 |
| CELLCEPT | 500 MG | TABLET | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02237484 |
| JAMP MYCOPHENOLIC ACID | 180 MG | TABLET (ENTERIC-COATED) | JAMP PHARMA CORPORATION | MARKETED | DIN 02518538 |
| JAMP MYCOPHENOLIC ACID | 360 MG | TABLET (ENTERIC-COATED) | JAMP PHARMA CORPORATION | MARKETED | DIN 02518511 |
| JAMP-MYCOPHENOLATE | 500 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02380382 |
Who else supplies MYCOPHENOLIC ACID worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. MYCOPHENOLIC ACID appears in 252 registered pack listings across 8 markets, published on 7 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.