PUREGON 833 UNIT — DIN 02243948
FOLLITROPIN BETA : 833 UNIT · ORGANON CANADA INC. · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is PUREGON?
PUREGON 833 UNIT contains FOLLITROPIN BETA : 833 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02243948, held by ORGANON CANADA INC., supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 10-Aug-2022. 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 PUREGON used for?
In female: PUREGON® (follitropin beta) is indicated for: • Development of multiple follicles in ovulatory patients participating in an Assisted Reproduction Technology (ART) program. • Induction of ovulation and pregnancy in anovulatory infertile females in whom the cause of infertility is functional and not due to primary ovarian failure. In male: PUREGON® is indicated for: • Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Follitropin Beta 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 Follitropin Beta, across 6 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 |
|---|---|---|---|---|
| ORGANON CANADA INC. | 1 | 1 | PUREGON | Sourceable in Canada |
| ORGANON CANADA LTD LTEE | 3 | 0 | PUREGON (600 IU), PUREGON 100 I.U., PUREGON 50 I.U. | No marketed DIN |
| MERCK CANADA INC | 2 | 0 | PUREGON | 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 | 833 UNIT |
|---|---|
| Dosage form | SOLUTION |
| Route | SUBCUTANEOUS |
| Pack configuration (monograph) | Boxes of PUREGON® solution for injection contain 1 cartridge of PUREGON® and 6 (300 IU and 600 IU cartridges) or 9 (900 IU cartridges) needles to be used with the PUREGON PEN®. Cartridges contain 833 IU of FSH activity per mL aqueous solution. Cartridges with a net dose of 300 IU contain a minimum of 400 IU in 0.480 mL; those of 600 IU contain a minimum of 700 IU in 0.840 mL; those of 900 IU contain a minimum of 1025 IU in 1.230 mL. |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Follitropin Beta |
|---|---|
| ATC code | G03GA06 |
| 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) | 02243948 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2243948 |
| Brand name | PUREGON |
| Generic / active ingredient | FOLLITROPIN BETA : 833 UNIT |
| Market authorization holder | ORGANON CANADA INC. |
| Health Canada schedule | Schedule D |
| ATC code | G03GA06 |
| ATC anatomical main group | G — Genito-urinary system and sex hormones |
| ATC therapeutic subgroup | G03GA |
| Current status | MARKETED |
| Status date | 10-Aug-2022 |
| 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 6 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| PUREGON | 50 UNIT / 0.5 ML | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | 02242439 |
| PUREGON | 100 UNIT / 0.5 ML | SOLUTION | MERCK CANADA INC | CANCELLED POST MARKET | 02242441 |
| PUREGON (600 IU) | 737 UNIT | POWDER FOR SOLUTION ; SOLUTION | ORGANON CANADA LTD LTEE | CANCELLED POST MARKET | 02243949 |
| PUREGON 100 I.U. | 1 ML | POWDER FOR SOLUTION ; LIQUID | ORGANON CANADA LTD LTEE | CANCELLED POST MARKET | 02231656 |
| PUREGON 50 I.U. | 50 UNIT | LIQUID ; POWDER FOR SOLUTION | ORGANON CANADA LTD LTEE | CANCELLED POST MARKET | 02231655 |
2 · Same class — other molecules in ATC G03GA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Follitropin Alfa | GONAL-F · GONAL-F PEN | 10 | 3 | Yes |
| Follitropin Delta | REKOVELLE | 6 | 3 | Yes |
| Combinations | PERGOVERIS | 4 | 3 | Yes |
| Chorionic Gonadotrophin | A.P.L. - PWS-LIQ · APL INJ 1000 IU/ML · CHORIONIC GONADOTROPIN FOR INJECTION, USP · PREGNYL · +2 more | 6 | 2 | Yes |
| Choriogonadotropin Alfa | OVIDREL | 2 | 2 | Yes |
| Follitropin Beta | PUREGON · PUREGON (600 IU) · PUREGON 100 I.U. · PUREGON 50 I.U. | 6 | 1 | Yes |
| Human Menopausal Gonadotrophin | HUMEGON INJ 75 I.U. · MENOPUR · PERGONAL 75 I.U. · REPRONEX | 4 | 1 | Yes |
| Urofollitropin | BRAVELLE · FERTINORM HP 150 - PWS DILUENT IM SC · FERTINORM HP 75 - PWS DILUENT IM SC · METRODIN 75 I.U. | 4 | 0 | Not in Canada |
| Lutropin Alfa | LUVERIS | 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 G03G
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| G03GB | Clomifene | 4 | 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.
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.