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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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TACROLIMUS

All products: Limited Use (codes 410)

Other products in the same Health Canada class (L04A, L04AD) — coverage varies; not interchangeable

  • Cyclosporine (Neoral): general benefit
  • Azathioprine (Imuran): general benefit
  • Leflunomide (Arava): general benefit
  • Mycophenolate mofetil (CellCept): general benefit, Limited Use 556
  • Mycophenolate (Myfortic): general benefit
  • Adalimumab (Hyrimoz): limited Use 600, 601, 602, 603, 604, 605, 606, 607, 609, 611, Limited Use 600, 602, 603, 604, 605, 606, 607, 609, 633, 634

15 more in the class list below

Sandoz Tacrolimus XR · DIN 02528622 · 3mg · extended release capsule

Limited Use — Reason for Use code 410 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 410 required
Write on scriptLU code 410 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 410
Reason for Use code 410 For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants Coverage limit: LU Authorization Period: Indefinite
1 brand, same coverage
Sandoz Tacrolimus XR · DIN 02528622 Manufacturer: Sandoz Canada Inc.; listing date 2025-12-30 Health Canada: Marketed since 2025-11-25 · brand SANDOZ TACROLIMUS XR · ATC L04AD02 TACROLIMUS · form Capsule (extended-release) · route Oral · ingredients TACROLIMUS 3 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Tacrolimus XR: Formulary list price $4.6853/unit (unit not stated in source; not the patient's cost)

Ministry pays: $4.6853 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101783 · Verify on the e-Formulary ↗ (DIN 02528622)

Source record
DIN 02528622: Sandoz Tacrolimus XR Raw flags: sec12=Y, sec3=Y Item: 920000621; group id 964; item number 2291; lccId 00200; manufacturer id SDZ Source form: ER Cap; strength: 3mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $4.6853; ministry $4.6853 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02528622 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101783
Interchangeable products
Advagraf · DIN 02331667 · $4.6853
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab

MYCOPHENOLATE MOFETIL

· 16 products · General benefit (14), Limited Use, codes 556 (2) · strengths: 250mg, 200mg/mL, 500mg · Cap, Pd for Oral Susp-175mL Pk, Tab

MYCOPHENOLATE SODIUM

· 8 products · General benefit · strengths: 180mg, 360mg · Ent Tab

LENALIDOMIDE

· 42 products · Limited Use, codes 630, 631, 632, 659, 741 · strengths: 2.5mg, 15mg, 20mg, 25mg, 5mg, 10mg · Cap

SIROLIMUS

· 2 products · Limited Use, codes 392 · strengths: 1mg/mL, 1mg · O/L, Tab

TERIFLUNOMIDE

· 10 products · Listed, not a benefit (1), Limited Use, codes 647 (9) · strengths: 14mg · Tab

USTEKINUMAB

· 14 products · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (2), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (2) · strengths: 45mg/0.5mL, 90mg/1.0mL, 90mg/mL, 130mg/26mL, 5mg/mL · Inj Sol-0.5mL Pref Autoinj (Preservative-Free), Inj Sol-0.5mL Pref Syr Pk, Inj Sol-0.5mL Pref Syr Pk (Preservative-Free), Inj Sol-0.5mL Vial Pk, Inj Sol-1.0mL Pref Syr Pk (Preservative-Free), Inj Sol-1mL Pref Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr Pk, Inj Sol-26mL Vial Pk, Inj Sol-26mL Vial Pk (Preservative-Free), Inj Sol-Vial Pk (Preservative-Free)

FINGOLIMOD

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg · Cap

PIRFENIDONE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 267mg · Cap

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 74 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: active rheumatoid arthritis
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. Covered without a code on the Ontario formulary: LEFLUNOMIDE, PENICILLAMINE, SULFASALAZINE CYCLOSPORINE · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (8) Rheumatoid Arthritis NEORAL capsules and oral solution (cyclosporine) are also indicated for the treatment of severe active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents are inappropriate or ineffective. PM: https://pdf.hres.ca/dpd_pm/00085584.PDF; date 2026-07-30; DIN 02150662; fetched 2026-09-10 Product monograph LEFLUNOMIDE · General benefit ARAVA is indicated in adults for the treatment of active rheumatoid arthritis. 1.1 Pediatrics The use in patients less than 18 years of age is contraindicated. 1.2 Geriatrics No dosage adjustment is needed in patients over 65 years of age. PM: https://pdf.hres.ca/dpd_pm/00083555.PDF; date not captured; DIN 02241888; fetched 2026-09-10 Product monograph PENICILLAMINE · General benefit INDICATIONS AND CLINICAL USE CUPRIMINE (penicillamine capsules, USP) is indicated for:  treatment of Wilson's disease  chronic lead poisoning  cystinuria, and  In patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. PM: https://pdf.hres.ca/dpd_pm/00054287.PDF; date not captured; DIN 00016055; fetched 2026-09-10 Product monograph SULFASALAZINE · General benefit It is especially useful for chronic administration. pms-SULFASALAZINE-E.C. is also indicated for the treatment of active rheumatoid arthritis, when treatment with an adequate conventional first line therapy has failed. PM: https://pdf.hres.ca/dpd_pm/00056638.PDF; date April 30, 2020; DIN 00598461; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS Transplantation Prograf® (tacrolimus) is indicated for: • prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants. • treatment of refractory rejection in patients receiving allogeneic liver or kidney transplants. Prograf is to be used concomitantly with adrenal corticosteroids and other immunosuppressive agents. The safety and efficacy of the use of Prograf with sirolimus has not been established. Only physicians experienced in immunosuppressive therapy and management of organ transplant should prescribe Prograf (tacrolimus). Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Rheumatoid Arthritis Prograf (tacrolimus immediate-release capsules, USP) is indicated for: • treatment of active rheumatoid arthritis in adult patients for whom disease modifying anti-rheumatic drug (DMARD) therapy is ineffective or inappropriate. Prograf may be used as monotherapy or in combination with non-st… https://pdf.hres.ca/dpd_pm/00082912.PDF PM date: 2025-12-17 Source product: PROGRAF; DIN 02175983; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.