OMNARIS HFA 50 MCG — DIN 02404311
CICLESONIDE : 50 MCG · TAKEDA CANADA INC · AEROSOL, METERED DOSE · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is OMNARIS HFA?
OMNARIS HFA 50 MCG contains CICLESONIDE : 50 MCG. It is listed in the Health Canada Drug Product Database under DIN 02404311, held by TAKEDA CANADA INC, supplied as AEROSOL, METERED DOSE for NASAL administration. Health Canada currently lists it as cancelled post market, status dated 10-Feb-2017. 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 OMNARIS HFA used for?
Treatment of seasonal allergic rhinitis (SAR), including hayfever, and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age and older.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Ciclesonide cost around the world?
Ciclesonide is listed on 8 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); Czechia publishes a max 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 |
|---|---|---|---|---|
| South Africa | single exit price | 5 | 8 | ZAR███.██ |
| Italy | prezzo al pubblico (classe A) | 5 | 5 | EUR███.██ |
| Australia | ex-manufacturer | 2 | 4 | AUD███.██ |
| Czechia | max producer price (ex-factory) | 2 | 3 | CZK███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
| Greece | producer price (ex-factory) | 3 | 3 | EUR███.██ |
| Saudi Arabia | public | 2 | 3 | SAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 2 | EUR███.██ |
31 pack listings across 24 brand entries and 8 price bases, refreshed 08 Sep 2026. Ranges span every Ciclesonide 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 Ciclesonide 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.
3 holders have a Canadian DIN containing Ciclesonide, across 3 DINs, of which 1 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 |
|---|---|---|---|---|
| COVIS PHARMA GMBH | 1 | 1 | OMNARIS | Sourceable in Canada |
| APOTEX INC | 1 | 0 | APO-CICLESONIDE | No marketed DIN |
| TAKEDA CANADA INC | 1 | 0 | OMNARIS HFA | 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 MCG |
|---|---|
| Dosage form | AEROSOL, METERED DOSE |
| Route | NASAL |
| Pack configuration (monograph) | 60 count canister. (Note: Canister and actuator may become separated if dropped). |
| Storage | Not explicitly stated in provided text (Summary section refers to STORAGE AND STABILITY on page 13, which is not in the snippet). |
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 | Ciclesonide |
|---|---|
| ATC code | R01AD13 |
| 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) | 02404311 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2404311 |
| Brand name | OMNARIS HFA |
| Generic / active ingredient | CICLESONIDE : 50 MCG |
| Market authorization holder | TAKEDA CANADA INC |
| Health Canada schedule | Prescription |
| ATC code | R01AD13 |
| ATC anatomical main group | R — Respiratory system |
| ATC therapeutic subgroup | R01AD |
| Current status | CANCELLED POST MARKET |
| Status date | 10-Feb-2017 |
| Original market date | 2013-08-07 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Adults and Adolescents (≥12 years): 1 actuation (50 mcg) per nostril once daily. Total daily dose: 100 mcg. Prime before first use (3 actuations) or if unused for 7 days.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to any ingredients. Use with caution in patients with active or quiescent tuberculosis infections of the respiratory tract.
Warnings and precautions
Risk of nasal septal ulcers/perforation, Candida infection, glaucoma/cataracts, immunosuppression, and HPA axis suppression. Avoid spraying directly onto the nasal septum.
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 3 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| OMNARIS | 50 MCG | SPRAY, METERED DOSE | COVIS PHARMA GMBH | MARKETED | 02303671 |
| APO-CICLESONIDE | 50 MCG | SPRAY, METERED DOSE | APOTEX INC | DORMANT | 02417316 |
2 · Same class — other molecules in ATC R01AD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Mometasone | APO-MOMETASONE · MOMETASONE · MOSASPRAY · NASAL ALLERGY AND CONGESTION RELIEF · +4 more | 9 | 6 | Yes |
| Fluticasone | 24HR NASAL ALLERGY RELIEF · ALLERGY RELIEF NASAL SPRAY · APO-FLUTICASONE · FLONASE - AEM-SUS NAS 50MCG/MD · +5 more | 9 | 4 | Yes |
| Budesonide | MYLAN-BUDESONIDE AQ · RHINOCORT AQUA · RHINOCORT AQUA 100MCG · RHINOCORT TURBUHALER 100 MCG/DOSE | 5 | 3 | Yes |
| Triamcinolone | APO-TRIAMCINOLONE AQ · NASACORT · NASACORT ALLERGY 24HR · NASACORT AQ · +1 more | 5 | 3 | Yes |
| Fluticasone, Combinations | APO-AZELASTINE/FLUTICASONE · DYMISTA · MYLAN-AZELASTINE/FLUTICASONE | 3 | 3 | Yes |
| Beclomethasone | APO-BECLOMETHASONE NASAL SPRAY · BECLOMETHASONE AQUEOUS NASAL SPRAY 50MCG/METERED DOSE · BECLOMETHASONE DIPROPIONATE NAS-SPR 50MCG/AEM · BECLOMETHASONE DIPROPIONATE NASAL INHALER · +8 more | 13 | 2 | Yes |
| Ciclesonide | APO-CICLESONIDE · OMNARIS · OMNARIS HFA | 3 | 1 | Yes |
| Fluticasone Furoate | AVAMYS | 1 | 1 | Yes |
| Mometasone, Combinations | RYALTRIS | 1 | 1 | Yes |
| Flunisolide | APO-FLUNISOLIDE NASAL SPRAY · NOVO-FLUNISOLIDE · PMS-FLUNISOLIDE · RATIO-FLUNISOLIDE · +2 more | 6 | 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 R01A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| R01AA | Ephedrine · Oxymetazoline · Phenylephrine · Xylometazoline | 76 | 18 |
| R01AX | Combinations · Ipratropium Bromide · Various | 42 | 4 |
| R01AB | Ephedrine · Naphazoline · Oxymetazoline · Phenylephrine | 12 | 1 |
| R01AC | Cromoglicic Acid · Levocabastine | 6 | 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.
What else is OMNARIS HFA called?
The same molecule, Ciclesonide, 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 |
|---|---|---|
| ALVESCO | Latin | Czechia |
| CICLESONIDE GLENMARK | Latin | Czechia |
| Omnair® | Latin | South Africa |
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.