ZEJULA 100 MG — DIN 02489783
NIRAPARIB (NIRAPARIB TOSYLATE) : 100 MG · GLAXOSMITHKLINE INC · CAPSULE · wholesale supply in Canada
Health Canada status: DORMANT
What is ZEJULA?
ZEJULA 100 MG contains NIRAPARIB (NIRAPARIB TOSYLATE) : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02489783, held by GLAXOSMITHKLINE INC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as dormant, status dated 26-Oct-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is ZEJULA used for?
As monotherapy for the maintenance treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. As monotherapy for the maintenance treatment of female adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Niraparib cost around the world?
Niraparib is listed on 10 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 | 8 | AUD███.██ |
| Italy | ex-factory (classe H) | 5 | 5 | EUR███.██ |
| Bahrain | retail (max) | 2 | 3 | BHD███.██ |
| Saudi Arabia | public | 2 | 3 | SAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 | EUR███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Hungary | producer price (ex-factory) | 2 | 2 | HUF███.██ |
| South Africa | single exit price | 2 | 2 | ZAR███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
| Slovakia | categorised final price | 1 | 1 | EUR███.██ |
29 pack listings across 20 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Niraparib 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 Niraparib 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 Niraparib — 2 DINs, of which 1 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 | 2 | 1 | ZEJULA | 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 | CAPSULE |
| Route | ORAL |
| Pack configuration (monograph) | ZEJULA capsules are packaged as unit dose blister in cartons of 56 × 1 and 84 × 1 capsules. ZEJULA tablets are packaged as unit dose blister in cartons of 28 × 1, 56 × 1, and 84 × 1 tablets. |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Niraparib |
|---|---|
| ATC code | L01XK02 |
| AHFS class | 84:80.00 |
| 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) | 02489783 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2489783 |
| Brand name | ZEJULA |
| Generic / active ingredient | NIRAPARIB (NIRAPARIB TOSYLATE) : 100 MG |
| Market authorization holder | GLAXOSMITHKLINE INC |
| Health Canada schedule | Prescription |
| ATC code | L01XK02 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01XK |
| Current status | DORMANT |
| Status date | 26-Oct-2024 |
| Original market date | 2020-02-07 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
1 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ZEJULA | 100 MG | TABLET | GLAXOSMITHKLINE INC | MARKETED | 02530031 |
2 · Same class — other molecules in ATC L01XK
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Talazoparib | TALZENNA | 5 | 2 | Yes |
| Olaparib | LYNPARZA | 3 | 2 | Yes |
| Niraparib And Abiraterone | AKEEGA | 2 | 2 | Yes |
| Niraparib | ZEJULA | 2 | 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 L01X
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01XX | Aflibercept · Altretamine · Amsacrine · Anagrelide · Arsenic Trioxide · +13 more | 48 | 23 |
| L01XG | Bortezomib · Carfilzomib · Ixazomib | 30 | 18 |
| L01XA | Carboplatin · Cisplatin · Oxaliplatin | 45 | 12 |
| L01XL | Axicabtagene Ciloleucel · Brexucabtagene Autoleucel · Ciltacabtagene Autoleucel · Idecabtagene Vicleucel · Lifileucel · +2 more | 8 | 5 |
| L01XJ | Glasdegib · Sonidegib · Vismodegib | 4 | 4 |
| L01XD | Aminolevulinic Acid · Methyl Aminolevulinate · Porfimer Sodium | 5 | 3 |
| L01XH | Romidepsin · Vorinostat | 2 | 2 |
| L01XF | Tretinoin | 2 | 2 |
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.
What else is ZEJULA called?
The same molecule, Niraparib, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Akeega | Latin | Bahrain, Saudi Arabia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
How can I get it?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.