FLAREX 0.1 % — DIN 00756784
FLUOROMETHOLONE ACETATE : 0.1 % · NOVARTIS PHARMACEUTICALS CANADA INC · SUSPENSION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is FLAREX?
FLAREX 0.1 % contains FLUOROMETHOLONE ACETATE : 0.1 %. It is listed in the Health Canada Drug Product Database under DIN 00756784, held by NOVARTIS PHARMACEUTICALS CANADA INC, supplied as SUSPENSION for OPHTHALMIC administration. Health Canada currently lists it as cancelled post market, status dated 20-Mar-2025. 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 FLAREX used for?
FLAREX ® (fluorometholone acetate ophthalmic suspension) is indicated for the treatment of allergic and other steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Fluorometholone cost around the world?
Fluorometholone 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. Bahrain publishes a retail (max); Czechia publishes a max producer price (ex-factory); Greece publishes a producer price (ex-factory). 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 |
|---|---|---|---|---|
| Saudi Arabia | public | 9 | 9 | SAR███.██ |
| United States | acquisition | 1 | 6 | USD███.██ |
| South Africa | single exit price | 4 | 4 | ZAR███.██ |
| Czechia | max producer price (ex-factory) | 3 | 3 | CZK███.██ |
| United Arab Emirates | public | 2 | 2 | AED███.██ |
| Bahrain | retail (max) | 2 | 2 | BHD███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Iceland | max wholesale | 2 | 2 | ISK███.██ |
| Luxembourg | reimbursement | 1 | 1 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 1 | MAD███.██ |
32 pack listings across 27 brand entries and 9 price bases, refreshed 05 Sep 2026. Ranges span every Fluorometholone pack in that market, so a high figure is usually a larger pack rather than the same product.
This table is a regulatory record of where the molecule is listed. The DIN on this page is no longer authorized for sale in Canada, so Nexara does not quote it — see the alternatives above.
Is there a generic Fluorometholone 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.
5 holders have a Canadian DIN containing Fluorometholone, across 5 DINs, of which 2 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 |
|---|---|---|---|---|
| ABBVIE CORPORATION | 1 | 1 | FML | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | SANDOZ FLUOROMETHOLONE | Sourceable in Canada |
| ALLERGAN INC | 1 | 0 | FML FORTE SUS 0.25% | No marketed DIN |
| NOVARTIS PHARMACEUTICALS CANADA INC | 1 | 0 | FLAREX | No marketed DIN |
| PHARMASCIENCE INC | 1 | 0 | PMS-FLUOROMETHOLONE | 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 | 0.1 % |
|---|---|
| Dosage form | SUSPENSION |
| Route | OPHTHALMIC |
| Pack configuration (monograph) | 5 mL DROP-TAINER dispensers |
| Storage | Protect from freezing. Store upright at room temperature. Keep out of the reach and sight of children. |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Fluorometholone |
|---|---|
| ATC code | S01BA07 |
| AHFS class | 52:08.08 |
| 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) | 00756784 |
|---|---|
| DIN (unpadded, as printed on some documents) | 756784 |
| Brand name | FLAREX |
| Generic / active ingredient | FLUOROMETHOLONE ACETATE : 0.1 % |
| Market authorization holder | NOVARTIS PHARMACEUTICALS CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | S01BA07 |
| ATC anatomical main group | S — Sensory organs |
| ATC therapeutic subgroup | S01BA |
| Current status | CANCELLED POST MARKET |
| Status date | 20-Mar-2025 |
| Original market date | 1987-12-31 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
2 of 5 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| FML | 0.1 % | SUSPENSION | ABBVIE CORPORATION | MARKETED | 00247855 |
| SANDOZ FLUOROMETHOLONE | 0.1 % | SUSPENSION | SANDOZ CANADA INCORPORATED | MARKETED | 00432814 |
| FML FORTE SUS 0.25% | 0.25 % | SUSPENSION | ALLERGAN INC | CANCELLED POST MARKET | 00707511 |
| PMS-FLUOROMETHOLONE | 0.1 % | SUSPENSION | PHARMASCIENCE INC | CANCELLED POST MARKET | 02238568 |
2 · Same class — other molecules in ATC S01BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Prednisolone | AK TATE OPH SUS 1% · DIOPRED SUSPENSION 1% · INFLAMASE FORTE OPH SOLN 1% · INFLAMASE FORTE OPHTHALMIC SOLUTION 1% · +12 more | 17 | 4 | Yes |
| Loteprednol | ALREX · LOTEMAX · LOTEMAX GEL · LOTEMAX OINTMENT | 4 | 4 | Yes |
| Dexamethasone | MAXIDEX · OCUDEX LIQ 0.1% · OZURDEX | 4 | 3 | Yes |
| Fluorometholone | FLAREX · FML · FML FORTE SUS 0.25% · PMS-FLUOROMETHOLONE · +1 more | 5 | 2 | Yes |
| Triamcinolone | TRIESENCE · XIPERE | 2 | 1 | Yes |
| Corticosteroids, Plain | DUREZOL | 1 | 1 | Yes |
| Fluocinolone Acetonide | ILUVIEN · RETISERT | 2 | 0 | Not in Canada |
| Hydrocortisone | CORTAMED ONT 25 MG/GM | 1 | 0 | Not in Canada |
| Medrysone | HMS | 1 | 0 | Not in Canada |
| Rimexolone | VEXOL OPHTHALMIC SUSPENSION - 1% | 1 | 0 | Not in Canada |
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 S01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| S01BC | Bromfenac · Diclofenac · Flurbiprofen · Indometacin · Ketorolac · +1 more | 22 | 10 |
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 FLAREX called?
The same molecule, Fluorometholone, 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 |
|---|---|---|
| Flucon | Latin | Czechia, Iceland, Morocco, South Africa |
| Efemoline | Latin | South Africa |
| EFFLUMIDEX LIQUIFILM | Latin | Czechia |
| FLUCA | Latin | Bahrain |
| FLUCA OPTHALMIC SUSP. | Latin | Saudi Arabia |
| FLUMETOL | Latin | Saudi Arabia |
| Fluoropos | Latin | Iceland |
| FML™ | Latin | United Arab Emirates |
| INFECTOFLAM EYE DROPS | Latin | Saudi Arabia |
| INFECTOFLAM EYE OINT. | Latin | Saudi Arabia |
| OPTILONE | Latin | Bahrain |
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.
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.