FULVESTRANT INJECTION 50 MG — DIN 02536293
FULVESTRANT : 50 MG · FORMATIVE PHARMA INC. · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is FULVESTRANT INJECTION?
FULVESTRANT INJECTION 50 MG contains FULVESTRANT : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02536293, held by FORMATIVE PHARMA INC., supplied as SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 18-Dec-2023. 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 FULVESTRANT INJECTION used for?
Treatment of ER+, HER2- locally advanced or metastatic breast cancer in postmenopausal women (not previously treated with endocrine therapy or following progression after anti-estrogen therapy).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Fulvestrant cost around the world?
Fulvestrant is listed on 18 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 |
|---|---|---|---|---|
| Spain | PVP con IVA (public price) | 18 | 18 | EUR███.██ |
| Hungary | producer price (ex-factory) | 11 | 14 | HUF███.██ |
| Sweden | AIP (pharmacy purchase price) | 10 | 12 | SEK███.██ |
| Romania | max producer price | 8 | 9 | RON███.██ |
| Italy | ex-factory (classe H) | 7 | 8 | EUR███.██ |
| Slovakia | categorised final price | 6 | 8 | EUR███.██ |
| South Africa | single exit price | 7 | 8 | ZAR███.██ |
| Saudi Arabia | public | 7 | 7 | SAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 6 | 6 | EUR███.██ |
| Czechia | max producer price (ex-factory) | 6 | 6 | CZK███.██ |
| Australia | ex-manufacturer | 5 | 5 | AUD███.██ |
| Bahrain | retail (max) | 5 | 5 | BHD███.██ |
| Greece | producer price (ex-factory) | 5 | 5 | EUR███.██ |
| Norway | max AUP (pharmacy retail) | 5 | 5 | NOK███.██ |
| United Arab Emirates | public | 4 | 4 | AED███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
| United Kingdom | hospital | 1 | 1 | GBP███.██ |
| Iceland | max wholesale | 1 | 1 | ISK███.██ |
124 pack listings across 114 brand entries and 16 price bases, refreshed 08 Sep 2026. Ranges span every Fulvestrant 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 Fulvestrant 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.
12 holders have a Canadian DIN containing Fulvestrant, across 12 DINs, of which 6 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| ASTRAZENECA CANADA INC | 1 | 1 | FASLODEX | Sourceable in Canada |
| FORMATIVE PHARMA INC. | 1 | 1 | FULVESTRANT INJECTION | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | FULVESTRANT INJECTABLE | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | FULVESTRANT INJECTION | Sourceable in Canada |
| STERIMAX INC | 1 | 1 | FULVESTRANT INJECTION | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 1 | TEVA-FULVESTRANT INJECTION | Sourceable in Canada |
| ACCORD HEALTHCARE INC | 1 | 0 | FULVESTRANT INJECTION | No marketed DIN |
| ACTAVIS PHARMA COMPANY | 1 | 0 | ACT FULVESTRANT | No marketed DIN |
| APOTEX INC | 1 | 0 | APO-FULVESTRANT | No marketed DIN |
| AURO PHARMA INC | 1 | 0 | FULVESTRANT INJECTION | No marketed DIN |
| EUGIA PHARMA INC. | 1 | 0 | FULVESTRANT INJECTION | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 1 | 0 | FULVESTRANT INJECTION | No marketed DIN |
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 | 50 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | 2 x 5 mL syringe package. |
| Storage | Not explicitly detailed in provided text (Table of Contents lists page 20, but text ends at page 16). Typically requires refrigeration. |
| 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 | Fulvestrant |
|---|---|
| ATC code | L02BA03 |
| 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) | 02536293 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2536293 |
| Brand name | FULVESTRANT INJECTION |
| Generic / active ingredient | FULVESTRANT : 50 MG |
| Market authorization holder | FORMATIVE PHARMA INC. |
| Health Canada schedule | Prescription |
| ATC code | L02BA03 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L02BA |
| Current status | MARKETED |
| Status date | 18-Dec-2023 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
500 mg IM as two 5 mL injections (one in each buttock) on days 0, 14, 28, then every 28 days. Administer slowly (1-2 minutes/injection).
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known hypersensitivity to fulvestrant or any excipients; pregnant or lactating women.
Warnings and precautions
Risk of injection site events (sciatica, neuropathy). Caution in patients with bleeding diatheses/anticoagulants. Potential for hepatotoxicity and hepatic failure. Potential risk of osteoporosis.
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
6 of 12 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| FASLODEX | 50 MG | SOLUTION | ASTRAZENECA CANADA INC | MARKETED | 02248624 |
| FULVESTRANT INJECTABLE | 50 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02530635 |
| FULVESTRANT INJECTION | 250 MG / 5 ML | SOLUTION | STERIMAX INC | MARKETED | 02558971 |
| FULVESTRANT INJECTION | 50 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02483610 |
| TEVA-FULVESTRANT INJECTION | 50 MG | SOLUTION | TEVA CANADA LIMITED | MARKETED | 02460130 |
| ACT FULVESTRANT | 50 MG | SOLUTION | ACTAVIS PHARMA COMPANY | CANCELLED PRE MARKET | 02463075 |
| APO-FULVESTRANT | 50 MG | SOLUTION | APOTEX INC | APPROVED | 02486350 |
| FULVESTRANT INJECTION | 50 MG | SOLUTION | ACCORD HEALTHCARE INC | CANCELLED POST MARKET | 02486792 |
| FULVESTRANT INJECTION | 50 MG | SOLUTION | AURO PHARMA INC | APPROVED | 02533111 |
| FULVESTRANT INJECTION | 50 MG | SOLUTION | EUGIA PHARMA INC. | APPROVED | 02536668 |
2 · Same class — other molecules in ATC L02BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Fulvestrant | ACT FULVESTRANT · APO-FULVESTRANT · FASLODEX · FULVESTRANT INJECTABLE · +2 more | 12 | 6 | Yes |
| Tamoxifen | APO-TAMOX TAB 10MG · APO-TAMOX TAB 20MG · DOM-TAMOXIFEN · MYLAN-TAMOXIFEN · +15 more | 24 | 4 | 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 L02B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L02BG | Aminogluthetimide · Anastrozole · Exemestane · Formestane · Letrozole | 79 | 39 |
| L02BX | Abiraterone · Degarelix · Relugolix | 27 | 20 |
| L02BB | Apalutamide · Bicalutamide · Darolutamide · Enzalutamide · Flutamide · +1 more | 46 | 11 |
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 FULVESTRANT INJECTION called?
The same molecule, Fulvestrant, 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 |
|---|---|---|
| Faslodex | Latin | Bahrain, Czechia, Norway, South Africa |
| Fulvestrant Accord | Latin | Australia, Czechia, Norway, Sweden |
| Fulvestrant Ever Pharma | Latin | Australia, Czechia, Norway, Sweden |
| Faslodex® | Latin | Sweden |
| Fulvestrant Sandoz | Latin | Australia, Czechia, Sweden |
| Fulvestrant Medical Valley | Latin | Norway, Sweden |
| Fulvestrant Reddy | Latin | Norway, Sweden |
| Fulvestrant Teva | Latin | Czechia, Sweden |
| Fuxran | Latin | Bahrain, Saudi Arabia |
| ERANFU | Latin | Bahrain |
| FASTELEV | Latin | South Africa |
| FLORISTIL | Latin | Bahrain |
| Frexivo | Latin | South Africa |
| Fuldexa | Latin | South Africa |
| Fultra | Latin | 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?
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. 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.