QISMETTE 21 3.0 MG
DROSPIRENONE : 3.0 MG ETHINYL ESTRADIOL : 0.030 MG · DIN 02416506 · LUPIN LIMITED
Health Canada status: APPROVED
What is QISMETTE 21?
QISMETTE 21 3.0 MG contains DROSPIRENONE : 3.0 MG ETHINYL ESTRADIOL : 0.030 MG. It is listed in the Health Canada Drug Product Database under DIN 02416506, held by LUPIN LIMITED, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 21-Nov-2013. 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 QISMETTE 21 used for?
Conception control; Treatment of moderate acne vulgaris in women >=16 years of age who desire contraception and have achieved menarche.
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 | 02416506 |
|---|---|
| Brand name | QISMETTE 21 |
| Generic / active ingredient | DROSPIRENONE : 3.0 MG ETHINYL ESTRADIOL : 0.030 MG |
| Manufacturer | LUPIN LIMITED |
| Strength | 3.0 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | G03AA12 DROSPIRENONE AND ESTROGEN |
| AHFS class | 68:12.00 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 21-Nov-2013 |
How is it administered?
Oral administration. Efficacy may be reduced by missed tablets or GI disturbances. Specific 21-day or 28-day regimens apply.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not specified in the provided text (refers to STORAGE AND STABILITY section on page 30).
How is it supplied?
Not explicitly detailed in the provided text (refers to 21 and 28 day formats).
Contraindications
Thrombophlebitis, thromboembolic disorders, CAD, valvular heart disease, hypertension (>=160/100), smoking over age 35, diabetes with vascular involvement, liver disease, breast/endometrial cancer.
Warnings and precautions
Cigarette smoking increases risk of serious cardiovascular effects; risk increases with age (>35) and smoking intensity. Does not protect against STIs/HIV. Risk of VTE, ATE, and hyperkalemia.
Is DROSPIRENONE AND ESTROGEN in shortage in Canada?
A Canadian shortage report is on file for this molecule: Active — reported by GLENMARK PHARMACEUTICALS CANADA INC., last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code G03AA12 DROSPIRENONE AND ESTROGEN. 10 of 20 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 |
|---|---|---|---|---|---|
| DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP | 0.02 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | DIN 02462060 |
| DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP 21 | 3 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | DIN 02421437 |
| DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP 28 | 0.03 MG | TABLET | GLENMARK PHARMACEUTICALS CANADA INC. | MARKETED | DIN 02421445 |
| MYA | 3.00 MG | TABLET | APOTEX INC | MARKETED | DIN 02415380 |
| YASMIN 21 | 0.03 MG | TABLET | BAYER INC | MARKETED | DIN 02261723 |
| YASMIN 28 | 0.03 MG | TABLET | BAYER INC | MARKETED | DIN 02261731 |
| YAZ | 3 MG | TABLET | BAYER INC | MARKETED | DIN 02321157 |
| YAZ PLUS | 3.00 MG | TABLET | BAYER INC | MARKETED | DIN 02387433 |
| ZAMINE 21 | 3 MG | TABLET | APOTEX INC | MARKETED | DIN 02410788 |
| ZAMINE 28 | 3 MG | TABLET | APOTEX INC | MARKETED | DIN 02410796 |
Who else supplies DROSPIRENONE AND ESTROGEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. DROSPIRENONE AND ESTROGEN appears in 7 registered pack listings across 2 markets, published on 2 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.