DIANE-35 2 MG
CYPROTERONE ACETATE : 2 MG ETHINYL ESTRADIOL : 35 MCG · DIN 02233542 · BAYER INC
Health Canada status: MARKETED
What is DIANE-35?
DIANE-35 2 MG contains CYPROTERONE ACETATE : 2 MG ETHINYL ESTRADIOL : 35 MCG. It is listed in the Health Canada Drug Product Database under DIN 02233542, held by BAYER INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 17-Dec-2007. 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 DIANE-35 used for?
Treatment of women with severe acne, with associated symptoms of androgenization (seborrhea, mild hirsutism), unresponsive to topical therapy and oral antibiotics.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
What else is DIANE-35 called?
The same molecule, CYPROTERONE AND ESTROGEN, 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 |
|---|---|---|
| Cyproterone Sandoz | Latin | Australia |
| Androcur | Latin | Australia, Morocco |
| CLIMEN TAB | Latin | Saudi Arabia |
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 | 02233542 |
|---|---|
| Brand name | DIANE-35 |
| Generic / active ingredient | CYPROTERONE ACETATE : 2 MG ETHINYL ESTRADIOL : 35 MCG |
| Manufacturer | BAYER INC |
| Strength | 2 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 | 17-Dec-2007 |
| Original market date | 1998-04-08 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) | 02233542 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2233542 |
| Brand name | DIANE-35 |
| Active ingredient / INN | CYPROTERONE ACETATE : 2 MG ETHINYL ESTRADIOL : 35 MCG |
| ATC code | G03HB01 |
| ATC anatomical main group | G — Genito-urinary system and sex hormones |
| ATC therapeutic subgroup | G03 |
| AHFS class | 92:92.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | BAYER INC |
How is it administered?
Taken orally. 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 explicitly detailed in provided text (refers to Storage and Stability section).
How is it supplied?
Not explicitly detailed in provided text (refers to Dosage Forms, Composition and Packaging section).
Which pack is which?
| Strength on the label | 2 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Packaging as described in the monograph | Not explicitly detailed in provided text (refers to Dosage Forms, Composition and Packaging section). |
| Storage | Not explicitly detailed in provided text (refers to Storage and Stability section). |
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
History of thromboembolic disorders, cerebrovascular/coronary artery disease, active liver disease, liver tumours, breast/estrogen-dependent cancer, undiagnosed vaginal bleeding, pregnancy.
Warnings and precautions
Increased risk of venous thromboembolism (VTE). Smoking increases cardiovascular risk. Discontinue if thromboembolic symptoms, jaundice, or severe headaches occur.
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 |
|---|---|---|---|---|---|
| CLÉO -35 | 0.035 MG | TABLET | ALTIUS HEALTHCARE INC | MARKETED | DIN 02436736 |
| CYESTRA-35 | 0.035 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | DIN 02290308 |
| 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 much does CYPROTERONE AND ESTROGEN cost around the world?
CYPROTERONE AND ESTROGEN is listed on 6 national price registers Nexara tracks, across 25 pack listings published on 6 different price bases. What each country publishes is set out below.
| Market | What that country publishes | Brands listed | Pack listings | As of |
|---|---|---|---|---|
| Australia | ex-manufacturer | 5 | 16 | 08 Sep 2026 |
| United Kingdom | hospital | 3 | 3 | 31 Aug 2026 |
| Greece | producer price (ex-factory) | 2 | 2 | 03 Sep 2026 |
| South Africa | single exit price | 2 | 2 | 01 Sep 2026 |
| Morocco | PPV (public price) | 1 | 1 | 05 Sep 2026 |
| Saudi Arabia | public | 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.