COSMEGEN 0.5 MG
DACTINOMYCIN : 0.5 MG · DIN 00213071 · RECORDATI RARE DISEASES CANADA INC
Health Canada status: MARKETED
What is COSMEGEN?
COSMEGEN 0.5 MG contains DACTINOMYCIN : 0.5 MG. It is listed in the Health Canada Drug Product Database under DIN 00213071, held by RECORDATI RARE DISEASES CANADA INC, supplied as POWDER FOR SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 01-Dec-2019. 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 COSMEGEN used for?
Gestational trophoblastic neoplasia, Wilms’ tumor, childhood rhabdomyosarcoma, and Ewing’s sarcoma.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
What else is COSMEGEN called?
The same molecule, DACTINOMYCIN, 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 |
|---|---|---|
| Cosmegen® Lyovac | Latin | United Arab Emirates |
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.
Product details and regulatory record
| DIN | 00213071 |
|---|---|
| Brand name | COSMEGEN |
| Generic / active ingredient | DACTINOMYCIN : 0.5 MG |
| Manufacturer | RECORDATI RARE DISEASES CANADA INC |
| Strength | 0.5 MG |
| Dosage form | POWDER FOR SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01DA01 DACTINOMYCIN |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 01-Dec-2019 |
| Original market date | 1963-12-31 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 00213071 |
|---|---|
| DIN (unpadded, as printed on some documents) | 213071 |
| Brand name | COSMEGEN |
| Active ingredient / INN | DACTINOMYCIN : 0.5 MG |
| ATC code | L01DA01 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01 |
| AHFS class | 10:00.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | RECORDATI RARE DISEASES CANADA INC |
How is it administered?
IV only. Dosage varies by indication; max 15 mcg/kg or 400-600 mcg/m2/day for 5 days per 2-week cycle. Calculate based on lean body mass for obese/edematous patients.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store at 15-30°C (implied by standard lyophilized powder handling, though specific range not explicitly in text, the monograph refers to ambient room temperature for dilutions).
How is it supplied?
Vials containing 0.5 mg (500 micrograms) of dactinomycin and 20.0 mg of mannitol.
Which pack is which?
| Strength on the label | 0.5 MG |
|---|---|
| Dosage form | POWDER FOR SOLUTION |
| Route | INTRAVENOUS |
| Packaging as described in the monograph | Vials containing 0.5 mg (500 micrograms) of dactinomycin and 20.0 mg of mannitol. |
| Storage | Store at 15-30°C (implied by standard lyophilized powder handling, though specific range not explicitly in text, the monograph refers to ambient room temperature for dilutions). |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Contraindications
Hypersensitivity to dactinomycin; administration at or about the time of infection with chicken pox or herpes zoster due to risk of severe generalized disease or death.
Warnings and precautions
Highly toxic, myelosuppressive, and a potent vesicant. Risk of veno-occlusive disease (primarily hepatic), especially in children <48 months. Carcinogenic and mutagenic.
Who else supplies DACTINOMYCIN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DACTINOMYCIN appears in 3 registered pack listings across 3 markets, published on 3 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 much does DACTINOMYCIN cost around the world?
DACTINOMYCIN is listed on 3 national price registers Nexara tracks, across 3 pack listings published on 3 different price bases. What each country publishes is set out below.
| Market | What that country publishes | Brands listed | Pack listings | As of |
|---|---|---|---|---|
| United Arab Emirates | public | 1 | 1 | 31 Aug 2026 |
| Iceland | max wholesale | 1 | 1 | 02 Sep 2026 |
| South Africa | single exit price | 1 | 1 | 01 Sep 2026 |
Why there are no figures here. These bases are not comparable. A Brazilian ex-factory ceiling, a Belgian pharmacy public price and a Japanese reimbursement rate answer three different questions, and none of them is what a product lands in Canada for. Putting them side by side would mislead in both directions, so Nexara publishes where a molecule is listed and on what basis, and quotes the delivered Canadian price per 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.