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

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LEVOTHYROXINE (SODIUM)

All products: not a benefit

Other products in the same Health Canada class (H03AA) — coverage varies; not interchangeable

  • Liothyronine (Cytomel): not a benefit

Apo-Levothyroxine · DIN 02550776 · 0.137mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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.
1 brand, same coverage
Apo-Levothyroxine · DIN 02550776 Manufacturer: Apotex Inc.; listing date 2025-04-30 Health Canada: Marketed since 2025-03-17 · brand APO-LEVOTHYROXINE · ATC H03AA01 LEVOTHYROXINE SODIUM · form Tablet · route Oral · ingredients LEVOTHYROXINE SODIUM 137 MCG · company Apotex inc · schedule Prescription
Check this DIN again · Health Canada product record

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=103955 · Verify on the e-Formulary ↗ (DIN 02550776)

Source record
DIN 02550776: Apo-Levothyroxine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683600031; group id 805; item number 1969; lccId None; manufacturer id APX Source form: Tab; strength: 0.137mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $0.1906; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02550776 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103955
Interchangeable products
Synthroid · DIN 02233852 · not recorded
Shortage status: resolved shortage (ended 2025-10-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02550776
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (68:36 Thyroids) and how they are covered

Matched class: 68:36 Thyroids

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: PROPYLTHIOURACIL 68:36 Thyroids

LIOTHYRONINE (SODIUM)

· 8 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mcg, 25mcg · Tab

PROPYLTHIOURACIL

· 2 products · General benefit · strengths: 50mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:36
Full class listing Related classes: 68:04 Corticosteroids, 68:08 Androgens, 68:12 Contraceptives, 68:16 Estrogens, 68:20 Anti-Diabetic Agents, 68:24 Parathyroid Agents, 68:28 Pituitary Agents, 68:32 Progestogens and Oral Contraceptives, 68:38 Anti-Thyroids Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS SYNTHROID® (levothyroxine sodium) is indicated for: Hypothyroidism SYNTHROID® is indicated as a replacement or supplemental therapy in patients of any age with primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism of any etiology, in any state (including pregnancy) except transient hypothyroidism during the recovery phase of subacute thyroiditis; Pituitary Thyrotropin (Thyroid-stimulating hormone, TSH) Suppression SYNTHROID® is indicated as an adjunct to surgery and radioactive iodine therapy in the management of thyrotropin-dependent well-differentiated papillary or follicular carcinoma of the thyroid. 1.1 Pediatrics Pediatrics (<18 years of age including neonates): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of SYNTHROID® in pediatric patients has been established. Therefore, Health Canada has authorized an indication for pediatric use (see 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Pediatric Dosage). 1.2 Geriatrics Geriatrics (≥65 years of age): SYNTHROID® is approved for use in the geriatric population. However, experience suggests that use in the ge… https://pdf.hres.ca/dpd_pm/00077309.PDF PM date: OCT 08, 2024 Source product: SYNTHROID; DIN 02171228; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Apo-Levothyroxine: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026