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TESTOSTERONE ENANTHATE

All injection strengths: Limited Use (codes 397)

Other products in the same Health Canada class (G03BA) — coverage varies; not interchangeable

  • Testosterone (Androgel): limited Use 397
  • Testosterone cypionate (Depo-Testosterone): limited Use 397, Not a benefit
  • Testosterone undecanoate (Andriol): limited Use 397, Not a benefit

Testosterone Enanthate Injection, USP · DIN 02536315 · 1000mg/5mL · Oily injection solution-5mL Pk

Limited Use — Reason for Use code 397 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 397 required
Write on scriptLU code 397 (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 397
Reason for Use code 397 For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria. Coverage limit: LU Authorization Period: 1 year
1 brand, same coverage
Testosterone Enanthate Injection, USP · DIN 02536315 Manufacturer: Hikma Canada Limited; listing date 2024-10-31 Health Canada: Marketed since 2024-01-30 · brand TESTOSTERONE ENANTHATE INJECTION, USP · ATC G03BA03 TESTOSTERONE · form Solution · route Intramuscular · ingredients TESTOSTERONE ENANTHATE 200 MG/ML · company Hikma canada limited · schedule Controlled drugs (cdsa iv)
Check this DIN again · Health Canada product record

Testosterone Enanthate Injection, USP: Formulary list price $35.5943/unit (unit not stated in source; not the patient's cost)

Ministry pays: $35.5943 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=102510 · Verify on the e-Formulary ↗ (DIN 02536315)

Source record
DIN 02536315: Testosterone Enanthate Injection, USP Raw flags: sec12=Y, sec3=Y Item: 680800014; group id 725; item number 1788; lccId 00176; manufacturer id HIK Source form: Oily Inj Sol-5mL Pk; strength: 1000mg/5mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $35.5943; ministry $35.5943 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02536315 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102510
Interchangeable products
Delatestryl · DIN 00029246 · not recorded
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (68:08 Androgens) and how they are covered

Matched class: 68:08 Androgens

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: DANAZOL 68:08 Androgens

TESTOSTERONE

· 5 products · Limited Use, codes 397 · strengths: 1% · 2.5g Foil Packet, 5.0g Foil Packet, Top Gel-5g Pk

TESTOSTERONE CYPIONATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 100mg/mL · Oily Inj Sol-10mL Pk

TESTOSTERONE UNDECANOATE

· 2 products · Listed, not a benefit (1), Limited Use, codes 397 (1) · strengths: 40mg · Cap

DANAZOL

· 2 products · General benefit · strengths: 100mg, 200mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:08
Full class listing Related classes: 68:04 Corticosteroids, 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, 68:36 Thyroids, 68:38 Anti-Thyroids Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: testosterone replacement therapy
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. No displayed matched alternative is a general benefit. TESTOSTERONE CYPIONATE · Listed, not a benefit (1), Limited Use, codes 397 (1) INDICATIONS AND CLINICAL USE TARO–TESTOSTERONE CYPIONATE INJECTION (testosterone cypionate injection) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). PM: https://pdf.hres.ca/dpd_pm/00066102.PDF; date May 26, 2022; DIN 02496003; fetched 2026-09-10 Product monograph TESTOSTERONE UNDECANOATE · Listed, not a benefit (1), Limited Use, codes 397 (1) INDICATIONS AND CLINICAL USE Taro-Testosterone (testosterone undecanoate capsules) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. PM: https://pdf.hres.ca/dpd_pm/00048154.PDF; date not captured; DIN 02421186; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE Testosterone Enanthate Injection, USP (testosterone enanthate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). Testosterone Enanthate Injection, USP should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other etiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate biochemical assays (morning testosterone) before initiating therapy with any testosterone replacement, including Testosterone Enanthate Injection, USP treatment. Geriatrics (> 65 years of age): There are limited controlled clinical study data supporting the use of testosterone enanthate in the geriatric population (see WARNINGS AND PRECAUTIONS and CLINICAL TRIALS). Pediatrics (< 18 years of age): Testosterone Enanthate Injection, USP is not indicated for use in children < 18 years of age since safety and … https://pdf.hres.ca/dpd_pm/00071616.PDF PM date: not printed or not captured Source product: TESTOSTERONE ENANTHATE INJECTION, USP; DIN 02536315; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.