ELMIRON 100 MG
PENTOSAN POLYSULFATE SODIUM : 100 MG · DIN 02029448 · JANSSEN INC
Health Canada status: MARKETED
What is ELMIRON?
ELMIRON 100 MG contains PENTOSAN POLYSULFATE SODIUM : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02029448, held by JANSSEN INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 13-Feb-2003. 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 ELMIRON used for?
ELMIRON® (pentosan polysulfate sodium) is indicated for the initial and maintenance treatment of interstitial cystitis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
What else is ELMIRON called?
Also recorded in Canada as: 7.5 ML pentosan polysulphate sodium 250 MG/ML Injection [Zycosan] (US), 7.5 ML pentosan polysulphate sodium 250 MG/ML Injection (US), PENTOSAN POLYSULFATE SODIUM (US).
Product details and regulatory record
| DIN | 02029448 |
|---|---|
| Brand name | ELMIRON |
| Generic / active ingredient | PENTOSAN POLYSULFATE SODIUM : 100 MG |
| Manufacturer | JANSSEN INC |
| Strength | 100 MG |
| Dosage form | CAPSULE |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C05BA04 PENTOSTAN POLYSULFATE SODIUM |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 13-Feb-2003 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02029448 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2029448 |
| Brand name | ELMIRON |
| Active ingredient / INN | PENTOSAN POLYSULFATE SODIUM : 100 MG |
| ATC code | C05BA04 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C05 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | JANSSEN INC |
How is it stored and handled?
Store at controlled room temperature (15°C to 30 °C).
How is it supplied?
Bottles of 100 capsules.
Which pack is which?
| Strength on the label | 100 MG |
|---|---|
| Dosage form | CAPSULE |
| Route | ORAL |
| Packaging as described in the monograph | Bottles of 100 capsules. |
| Storage | Store at controlled room temperature (15°C to 30 °C). |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
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.