PROTOPIC 0.03 %
TACROLIMUS : 0.03 % · DIN 02244149 · LEO PHARMA INC
Health Canada status: MARKETED
What is PROTOPIC?
PROTOPIC 0.03 % contains TACROLIMUS : 0.03 %. It is listed in the Health Canada Drug Product Database under DIN 02244149, held by LEO PHARMA INC, supplied as OINTMENT for TOPICAL administration. Health Canada currently lists it as marketed, status dated 25-May-2017. 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 PROTOPIC used for?
Protopic, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years is indicated as a second-line therapy for short and long-term intermittent treatment of moderate to severe atopic dermatitis in non-immunocompromised patients, in whom the use of conventional therapies are deemed inadvisable because of potential risks, or who are not adequately responsive to or intolerant of conventional therapies. Protopic is also indicated for maintenance therapy to prevent flares and prolong flare-free intervals in patients with moderate to severe atopic dermatitis experiencing a high frequency of flares (i.e., occurring 5 or more times per year) who have had an initial response (i.e., lesions cleared, almost cleared or mildly affected) with up to 6 weeks of treatment with twice daily Protopic.
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 | 02244149 |
|---|---|
| Brand name | PROTOPIC |
| Generic / active ingredient | TACROLIMUS : 0.03 % |
| Manufacturer | LEO PHARMA INC |
| Strength | 0.03 % |
| Dosage form | OINTMENT |
| Route of administration | TOPICAL |
| Schedule | Prescription |
| ATC code | D11AH01 TACROLIMUS |
| AHFS class | 88:28.01* ; See footnote |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 25-May-2017 |
| Original market date | 2001-07-18 00:00:00 |
How is it stored and handled?
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How is it supplied?
Available in laminate tubes of 30, 60 and 100 grams.
What can be used instead?
Other Canadian products sharing ATC code D11AH01 TACROLIMUS. 2 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 |
|---|---|---|---|---|---|
| PROTOPIC | 0.1 % | OINTMENT | LEO PHARMA INC | MARKETED | DIN 02244148 |
| LEO PHARMA - TACROLIMUS | 0.03 % | OINTMENT | LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC. | APPROVED | DIN 02531399 |
| LEO PHARMA - TACROLIMUS | 0.1 % | OINTMENT | LEO PHARMA GEN, A DIVISION OF LEO PHARMA INC. | APPROVED | DIN 02531380 |
Who else supplies TACROLIMUS worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TACROLIMUS appears in 609 registered pack listings across 14 markets, published on 11 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.