CELLCEPT 250 MG
MYCOPHENOLATE MOFETIL : 250 MG · DIN 02192748 · HOFFMANN-LA ROCHE LIMITED
Health Canada status: MARKETED
What is CELLCEPT?
CELLCEPT 250 MG contains MYCOPHENOLATE MOFETIL : 250 MG. It is listed in the Health Canada Drug Product Database under DIN 02192748, held by HOFFMANN-LA ROCHE LIMITED, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 31-Dec-1995. 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 used for?
CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids. CellCept i.v. is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept i.v. should be administered within 24 hours following transplantation. CellCept i.v. can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication. In pediatric patients (2 to 18 years) CellCept is indicated for the prophylaxis of organ rejection receiving allogeneic renal transplants, and should be 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 | 02192748 |
|---|---|
| Brand name | CELLCEPT |
| Generic / active ingredient | MYCOPHENOLATE MOFETIL : 250 MG |
| Manufacturer | HOFFMANN-LA ROCHE LIMITED |
| Strength | 250 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | L04AA06 MYCOPHENOLIC ACID |
| AHFS class | 90:28.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 31-Dec-1995 |
| Original market date | 1995-12-31 00:00:00 |
How is it stored and handled?
Store reconstituted suspension at 15 - 30ºC. Do not freeze.
How is it supplied?
CellCept capsules are oblong, blue/brown, two-piece hard gelatin capsules, printed in black with "CellCept 250" on the blue cap and "Roche" on the brown body. They are provided in unit dose of 10 capsules in blister packs, 10 packs per box. CellCept tablets are lavender coloured, caplet-shaped, film coated tablets, engraved with “CellCept 500" on one side and “Roche” on the other. They are provided in unit dose of 10 tablets in blister packs, 5 packs per box. CellCept powder for oral suspension is supplied as a white to off-white powder blend for reconstitution to a white to off-white fruit flavour suspension. It is provided in a 225 mL bottle with bottle adapter and 2 oral dispensers*. The deliverable volume after reconstitution is 165 mL. CellCept i.v. is supplied in a 20 mL, sterile vial containing the equivalent of 500 mg MMF, as the hydrochloride salt in cartons of 4 vials. Each vial is intended for single use only.
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 | 500 MG | TABLET | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02237484 |
| CELLCEPT I.V. | 500 MG | POWDER FOR SOLUTION | HOFFMANN-LA ROCHE LIMITED | MARKETED | DIN 02240347 |
| 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.