CLÉO -35 0.035 MG
ETHINYL ESTRADIOL : 0.035 MG CYPROTERONE ACETATE : 2 MG · DIN 02436736 · ALTIUS HEALTHCARE INC
Health Canada status: MARKETED
What is CLÉO -35?
CLÉO -35 0.035 MG contains ETHINYL ESTRADIOL : 0.035 MG CYPROTERONE ACETATE : 2 MG. It is listed in the Health Canada Drug Product Database under DIN 02436736, held by ALTIUS HEALTHCARE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 04-May-2018. 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 CLÉO -35 used for?
Treatment of women with severe acne, unresponsive to oral antibiotic and other treatments, with associated symptoms of androgenization, including seborrhea and mild hirsutism.
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 | 02436736 |
|---|---|
| Brand name | CLÉO -35 |
| Generic / active ingredient | ETHINYL ESTRADIOL : 0.035 MG CYPROTERONE ACETATE : 2 MG |
| Manufacturer | ALTIUS HEALTHCARE INC |
| Strength | 0.035 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | G03HB01 CYPROTERONE AND ESTROGEN |
| AHFS class | 92:92.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 04-May-2018 |
| Original market date | 2015-10-30 00:00:00 |
How is it administered?
Administered in a cyclic manner. Should be discontinued 3 to 4 cycles after signs have completely resolved. Not for contraception alone.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not specified in the provided text.
How is it supplied?
Not explicitly detailed in provided text (mentions cyclic administration).
Contraindications
Thrombophlebitis, thromboembolic disorders, cerebrovascular/coronary artery disease, liver disease/tumours, cholestatic jaundice, breast/estrogen-dependent cancer, undiagnosed vaginal bleeding.
Warnings and precautions
Increased risk of VTE/ATE. Smoking increases cardiovascular risk (especially >35 years). Discontinue if visual defects, jaundice, or severe headache occur. Potential genotoxicity.
What can be used instead?
Other Canadian products sharing ATC code G03HB01 CYPROTERONE AND ESTROGEN. 5 of 6 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 |
|---|---|---|---|---|---|
| CYESTRA-35 | 0.035 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | DIN 02290308 |
| DIANE-35 | 2 MG | TABLET | BAYER INC | MARKETED | DIN 02233542 |
| TARO-CYPROTERONE/ETHINYL ESTRADIOL | 2 MG | TABLET | SUN PHARMA CANADA INC | MARKETED | DIN 02425017 |
| TEVA-CYPROTERONE / ETHINYL ESTRADIOL | 2 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02309556 |
| MYLAN-CYPROTERONE / ETHINYLESTRADIOL | 2 MG | TABLET | MYLAN PHARMACEUTICALS ULC | CANCELLED PRE MARKET | DIN 02491257 |
Who else supplies CYPROTERONE AND ESTROGEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. CYPROTERONE AND ESTROGEN appears in 75 registered pack listings across 10 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.