ORGALUTRAN 250 MCG / 0.5 ML
GANIRELIX (GANIRELIX ACETATE) : 250 MCG / 0.5 ML · DIN 02245641 · ORGANON CANADA INC.
Health Canada status: MARKETED
What is ORGALUTRAN?
ORGALUTRAN 250 MCG / 0.5 ML contains GANIRELIX (GANIRELIX ACETATE) : 250 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02245641, held by ORGANON CANADA INC., supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 17-May-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 ORGALUTRAN used for?
Prevention of premature LH surges in women undergoing controlled ovarian hyperstimulation (COH).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02245641 |
|---|---|
| Brand name | ORGALUTRAN |
| Generic / active ingredient | GANIRELIX (GANIRELIX ACETATE) : 250 MCG / 0.5 ML |
| Manufacturer | ORGANON CANADA INC. |
| Strength | 250 MCG / 0.5 ML |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Prescription |
| ATC code | H01CC01 GANIRELIX |
| AHFS class | 92:40.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 17-May-2022 |
| Original market date | 2002-08-23 00:00:00 |
How is it administered?
250 mcg SC once daily starting Day 2 or 3 of FSH therapy until hCG administration. Time between injections and between last dose and hCG should not exceed 30 hours.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text snippet (section 11 header present but content missing), though typically 15-30°C for this class.
How is it supplied?
Disposable pre-filled 1 mL glass syringes containing 250 mcg/0.5 mL. Available with or without natural rubber latex in the needle shield.
Contraindications
Hypersensitivity to ganirelix, GnRH analogs, or latex (needle shield); known/suspected pregnancy or lactation; moderate to severe renal or hepatic impairment.
Warnings and precautions
Risk of hypersensitivity/anaphylaxis. Needle shield may contain latex. Efficacy/safety not established in women <50kg or >90kg. Risk of OHSS and ectopic pregnancy.
Who else supplies GANIRELIX worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. GANIRELIX appears in 72 registered pack listings across 10 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
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.
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.
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.