MYLAN-NABUMETONE 500 MG
NABUMETONE : 500 MG · DIN 02244563 · MYLAN PHARMACEUTICALS ULC
Health Canada status: CANCELLED POST MARKET
What is MYLAN-NABUMETONE?
MYLAN-NABUMETONE 500 MG contains NABUMETONE : 500 MG. It is listed in the Health Canada Drug Product Database under DIN 02244563, held by MYLAN PHARMACEUTICALS ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 09-Jan-2017. 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 MYLAN-NABUMETONE used for?
Acute and chronic relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
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 | 02244563 |
|---|---|
| Brand name | MYLAN-NABUMETONE |
| Generic / active ingredient | NABUMETONE : 500 MG |
| Manufacturer | MYLAN PHARMACEUTICALS ULC |
| Strength | 500 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | M01AX01 NABUMETONE |
| AHFS class | 28:08.04.92 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 09-Jan-2017 |
| Original market date | 2002-02-20 00:00:00 |
How is it administered?
Starting/usual adult dose: 1000 mg daily as a single dose with or without food. Some patients may need 1500-2000 mg/day. Use lowest effective dose.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refer to STORAGE AND STABILITY section on page 16, which is not in the snippet).
How is it supplied?
Not explicitly detailed in provided text (mentions 'bottles' and 'components of the container' generally).
Contraindications
Hypersensitivity to nabumetone or NSAIDs; active peptic ulcer/GI inflammatory disease; severe renal impairment; nasal polyps/asthma/urticaria induced by ASA/NSAIDs; significant hepatic impairment.
Warnings and precautions
Risk of GI ulceration, bleeding, perforation; cardiovascular fluid retention/edema; potential for aseptic meningitis; may mask infection; risk of hyperkalemia; potential for severe skin reactions.
What can be used instead?
Other Canadian products sharing ATC code M01AX01 NABUMETONE. 1 of 12 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 |
|---|---|---|---|---|---|
| NABUMETONE | 500 MG | TABLET | AA PHARMA INC | MARKETED | DIN 02238639 |
| NABUMETONE | 500 MG | TABLET | SANIS HEALTH INC | CANCELLED POST MARKET | DIN 02343282 |
| NABUMETONE | 500 MG | TABLET | APOTEX INC | APPROVED | DIN 02238369 |
| NABUMETONE-500 | 500 MG | TABLET | PRO DOC LIMITEE | CANCELLED POST MARKET | DIN 02239113 |
| PMS-NABUMETONE | 500 MG | TABLET | PHARMASCIENCE INC | CANCELLED PRE MARKET | DIN 02238759 |
| PMS-NABUMETONE | 750 MG | TABLET | PHARMASCIENCE INC | CANCELLED PRE MARKET | DIN 02238760 |
| RELAFEN TABLETS 500MG | 500 MG | TABLET | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 02083531 |
| RELAFEN TABLETS 750MG | 750 MG | TABLET | GLAXOSMITHKLINE INC | CANCELLED POST MARKET | DIN 02083558 |
| SANDOZ NABUMETONE | 500 MG | TABLET | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | DIN 02242912 |
| TEVA-NABUMETONE | 500 MG | TABLET | TEVA CANADA LIMITED | CANCELLED POST MARKET | DIN 02240867 |
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.