DEMULEN 50 (21 DAY PACK) 50 MCG
ETHINYL ESTRADIOL : 50 MCG ETHYNODIOL DIACETATE : 1 MG · DIN 00028630 · PFIZER CANADA ULC
Health Canada status: CANCELLED POST MARKET
What is DEMULEN 50 (21 DAY PACK)?
DEMULEN 50 (21 DAY PACK) 50 MCG contains ETHINYL ESTRADIOL : 50 MCG ETHYNODIOL DIACETATE : 1 MG. It is listed in the Health Canada Drug Product Database under DIN 00028630, held by PFIZER CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 01-Apr-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 DEMULEN 50 (21 DAY PACK) used for?
Prevention of pregnancy. Demulen 50 is for cases where low-dose estrogen formulations prove unacceptable.
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 | 00028630 |
|---|---|
| Brand name | DEMULEN 50 (21 DAY PACK) |
| Generic / active ingredient | ETHINYL ESTRADIOL : 50 MCG ETHYNODIOL DIACETATE : 1 MG |
| Manufacturer | PFIZER CANADA ULC |
| Strength | 50 MCG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | G03AA01 ETYNODIOL AND ESTROGEN |
| AHFS class | 68:12.00 |
| Biosimilar | No |
| Health Canada status | CANCELLED POST MARKET |
| Status date | 01-Apr-2005 |
| Original market date | 1970-12-31 00:00:00 |
How is it administered?
One tablet daily at the same time for 21 days, followed by 7 days off (21-day pack) or 7 days of inert tablets (28-day pack). Start on Day 1, Day 5, or first Sunday of cycle.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly specified in the provided text.
How is it supplied?
21-day dispensers (21 active tablets) and 28-day dispensers (21 active and 7 inert tablets).
Contraindications
Thrombophlebitis, thromboembolic disorders, cerebrovascular/coronary artery disease, liver tumours/disease, breast or estrogen-dependent carcinoma, undiagnosed vaginal bleeding, pregnancy.
Warnings and precautions
Cigarette smoking increases risk of serious cardiovascular side effects, especially in women over 35. Discontinue if thromboembolic disorders, visual defects, or severe headaches occur.
What can be used instead?
Other Canadian products sharing ATC code G03AA01 ETYNODIOL AND ESTROGEN. 0 of 4 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 |
|---|---|---|---|---|---|
| DEMULEN 30 (21 DAY PACK) | 30 MCG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 00469327 |
| DEMULEN 30 (28 DAY PACK) | 2 MG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 00471526 |
| DEMULEN 50 (28 DAY PACK) | 1 MG | TABLET | PFIZER CANADA ULC | CANCELLED POST MARKET | DIN 00343536 |
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.