GONAL-F PEN 300 UNIT / 0.5 ML
FOLLITROPIN ALFA : 300 UNIT / 0.5 ML · DIN 02270404 · EMD SERONO, A DIVISION OF EMD INC., CANADA
Health Canada status: MARKETED
What is GONAL-F PEN?
GONAL-F PEN 300 UNIT / 0.5 ML contains FOLLITROPIN ALFA : 300 UNIT / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02270404, held by EMD SERONO, A DIVISION OF EMD INC., CANADA, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 06-Sep-2005. 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 GONAL-F PEN used for?
GONAL-f® (Follitropin alfa for Injection) is indicated for the stimulation of multiple follicular development in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization. It is also indicated for the stimulation of follicular development in patients with hypothalamic-pituitary dysfunction who present either oligomenorrhoea or amenorrhoea (WHO Group II).
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 | 02270404 |
|---|---|
| Brand name | GONAL-F PEN |
| Generic / active ingredient | FOLLITROPIN ALFA : 300 UNIT / 0.5 ML |
| Manufacturer | EMD SERONO, A DIVISION OF EMD INC., CANADA |
| Strength | 300 UNIT / 0.5 ML |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS |
| Schedule | Prescription |
| ATC code | G03GA05 FOLLITROPIN ALFA |
| AHFS class | 68:18.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 06-Sep-2005 |
| Original market date | 2005-09-06 00:00:00 |
How is it stored and handled?
null
How is it supplied?
1 prefilled pen and 8 needles to be used with the pen for subcutaneous administration (300 IU/0.48 mL), 1 prefilled pen and 12 needles to be used with the pen for subcutaneous administration (450 IU/0.72 mL), 1 prefilled pen and 20 needles to be used with the pen for subcutaneous administration (900 IU/1.44 mL)
What can be used instead?
Other Canadian products sharing ATC code G03GA05 FOLLITROPIN ALFA. 3 of 10 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| GONAL-F PEN | 450 UNIT / 0.75 ML | SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | MARKETED | DIN 02270390 |
| GONAL-F PEN | 900 UNIT / 1.5 ML | SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | MARKETED | DIN 02270382 |
| GONAL-F | 1200 UNIT | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02244787 |
| GONAL-F | 150 UNIT | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02231465 |
| GONAL-F | 33 MCG | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02248156 |
| GONAL-F | 37.5 UNIT | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02243004 |
| GONAL-F | 5.5 MCG | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02248154 |
| GONAL-F | 75 UNIT | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02231464 |
| GONAL-F | 77 MCG | POWDER FOR SOLUTION | EMD SERONO, A DIVISION OF EMD INC., CANADA | CANCELLED POST MARKET | DIN 02248157 |
Who else supplies FOLLITROPIN ALFA worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FOLLITROPIN ALFA appears in 53 registered pack listings across 11 markets, published on 9 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.