NUCALA 100 MG — DIN 02449781
MEPOLIZUMAB : 100 MG · GLAXOSMITHKLINE INC · POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is NUCALA?
NUCALA 100 MG contains MEPOLIZUMAB : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02449781, held by GLAXOSMITHKLINE INC, supplied as POWDER FOR SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as cancelled post market, status dated 06-Dec-2023. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is NUCALA used for?
Add-on maintenance for severe eosinophilic asthma (≥6 years), chronic rhinosinusitis with nasal polyps (adults), eosinophilic granulomatosis with polyangiitis (adults), and hypereosinophilic syndrome.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Mepolizumab cost around the world?
Mepolizumab is listed on 13 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Austria publishes a KVP (Kassenverkaufspreis); Bahrain publishes a retail (max). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| Australia | ex-manufacturer | 1 | 12 | AUD███.██ |
| Luxembourg | reimbursement | 9 | 9 | EUR███.██ |
| Italy | prezzo al pubblico (classe A) | 6 | 6 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 1 | 5 | NOK███.██ |
| Bahrain | retail (max) | 1 | 4 | BHD███.██ |
| Saudi Arabia | public | 2 | 4 | SAR███.██ |
| United Arab Emirates | public | 2 | 3 | AED███.██ |
| Austria | KVP (Kassenverkaufspreis) | 3 | 3 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 1 | 3 | CZK███.██ |
| Greece | producer price (ex-factory) | 3 | 3 | EUR███.██ |
| Hungary | producer price (ex-factory) | 3 | 3 | HUF███.██ |
| Slovakia | categorised final price | 2 | 2 | EUR███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
58 pack listings across 35 brand entries and 11 price bases, refreshed 08 Sep 2026. Ranges span every Mepolizumab pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Mepolizumab in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
Only one market authorization holder has a Canadian DIN containing Mepolizumab — 4 DINs, of which 3 are currently marketed. There is no second Canadian source today, so a supply interruption on this holder has no domestic substitute at the same molecule.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| GLAXOSMITHKLINE INC | 4 | 3 | NUCALA | Sourceable in Canada |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 100 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | SUBCUTANEOUS |
| Pack configuration (monograph) | 10 mL glass vial (lyophilized powder); 1 mL pre-filled autoinjector; 1 mL pre-filled syringe; 0.4 mL pre-filled syringe. |
| Storage | Lyophilized powder: Store below 25°C. Reconstituted solution: Store below 30°C (do not freeze, discard after 8h). Pre-filled formats: Store at 2-8°C, do not freeze. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Mepolizumab |
|---|---|
| ATC code | R03DX09 |
| AHFS class | 90:28.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02449781 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2449781 |
| Brand name | NUCALA |
| Generic / active ingredient | MEPOLIZUMAB : 100 MG |
| Market authorization holder | GLAXOSMITHKLINE INC |
| Health Canada schedule | Prescription |
| ATC code | R03DX09 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R03DX |
| Current status | CANCELLED POST MARKET |
| Status date | 06-Dec-2023 |
| Original market date | 2016-03-14 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adults/Adolescents (≥12): 100 mg SC every 4 weeks. Children (6-11): 40 mg SC every 4 weeks. EGPA/HES: 300 mg (as 3 x 100 mg injections) SC every 4 weeks.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to mepolizumab, to any ingredient in the formulations, or component of the containers.
Warnings and precautions
Not for acute asthma/status asthmaticus. Risk of hypersensitivity/anaphylaxis. Treat pre-existing helminth infections. Consider varicella vaccination for herpes zoster risk.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
3 of 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| NUCALA | 100 MG | SOLUTION | GLAXOSMITHKLINE INC | MARKETED | 02492989 |
| NUCALA | 100 MG | SOLUTION | GLAXOSMITHKLINE INC | MARKETED | 02492997 |
| NUCALA | 40 MG / 0.4 ML | SOLUTION | GLAXOSMITHKLINE INC | MARKETED | 02530821 |
2 · Same class — other molecules in ATC R03DX
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Omalizumab | OMLYCLO · XOLAIR | 9 | 8 | Yes |
| Mepolizumab | NUCALA | 4 | 3 | Yes |
| Benralizumab | FASENRA · FASENRA PEN | 2 | 2 | Yes |
| Tezepelumab | TEZSPIRE | 2 | 2 | Yes |
| Reslizumab | CINQAIR | 1 | 1 | Yes |
| Roflumilast | DAXAS | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC R03D
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R03DC | Montelukast · Zafirlukast | 98 | 41 |
| R03DA | Aminophylline · Choline Theophyllinate · Diprophylline · Theophylline · Theophylline, Combinations Excl. Psycholeptics | 82 | 8 |
| R03DB | Theophylline And Adrenergics | 1 | 0 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.