ACTIVELLE LD 0.5 MG
ESTRADIOL : 0.5 MG NORETHINDRONE ACETATE : 0.1 MG · DIN 02309009 · NOVO NORDISK CANADA INC
Health Canada status: MARKETED
What is ACTIVELLE LD?
ACTIVELLE LD 0.5 MG contains ESTRADIOL : 0.5 MG NORETHINDRONE ACETATE : 0.1 MG. It is listed in the Health Canada Drug Product Database under DIN 02309009, held by NOVO NORDISK CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 16-May-2008. 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 ACTIVELLE LD used for?
Treatment of moderate to severe vasomotor symptoms occurring in naturally or surgically induced estrogen deficiency states associated with menopause in women with intact uteri.
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 | 02309009 |
|---|---|
| Brand name | ACTIVELLE LD |
| Generic / active ingredient | ESTRADIOL : 0.5 MG NORETHINDRONE ACETATE : 0.1 MG |
| Manufacturer | NOVO NORDISK CANADA INC |
| Strength | 0.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | G03FA01 NORETHISTERONE AND ESTROGEN |
| AHFS class | 68:32.00 ; 68:16.04 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 16-May-2008 |
| Original market date | 2008-05-16 00:00:00 |
How is it administered?
One tablet taken orally once a day without interruption, preferably at the same time every day. Re-evaluate within 3-6 months.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (section 11 not included in snippet).
How is it supplied?
Calendar dial packs of 1x28 tablets or 3x28 tablets.
Contraindications
Hypersensitivity; liver disease; estrogen/progestin-dependent neoplasia; endometrial hyperplasia; breast cancer; undiagnosed genital bleeding; pregnancy; arterial/venous thromboembolism; porphyria.
Warnings and precautions
Increased risk of MI, stroke, invasive breast cancer, pulmonary emboli, DVT, and dementia. Use lowest effective dose for shortest duration. Monitor blood pressure and breast health.
What can be used instead?
Other Canadian products sharing ATC code G03FA01 NORETHISTERONE AND ESTROGEN. 4 of 5 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 |
|---|---|---|---|---|---|
| ACTIVELLE | 1 MG | TABLET | NOVO NORDISK CANADA INC | MARKETED | DIN 02249405 |
| ESTALIS 140/50 MCG | 140 MCG / 50MCG | PATCH | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02241835 |
| ESTALIS 250/50 MCG | 250 MCG / 24 HOUR | PATCH | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02241837 |
| FEMHRT | 5 MCG | TABLET | WARNER CHILCOTT CANADA CO | CANCELLED POST MARKET | DIN 02242531 |
Who else supplies NORETHISTERONE AND ESTROGEN worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NORETHISTERONE AND ESTROGEN appears in 14 registered pack listings across 8 markets, published on 7 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.