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

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PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

All products: not a benefit

Other products in the same Health Canada class (N04B) — coverage varies; not interchangeable

  • Entacapone (Comtan): limited Use 367

Sandoz Pramipexole · DIN 02315270 · 0.5mg · 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
Sandoz Pramipexole · DIN 02315270 Manufacturer: Sandoz Canada Inc.; listing date 2009-05-20 Health Canada: Marketed since 2008-08-14 · brand SANDOZ PRAMIPEXOLE · ATC N04BC05 PRAMIPEXOLE · form Tablet · route Oral · ingredients PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG · company Sandoz canada incorporated · 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=80081 · Verify on the e-Formulary ↗ (DIN 02315270)

Source record
DIN 02315270: Sandoz Pramipexole Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 289200011; group id 543; item number 1463; lccId None; manufacturer id SDZ Source form: Tab; strength: 0.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.3860; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02315270 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80081
Interchangeable products
Act Pramipexole · DIN 02297310 · not recorded Apo-Pramipexole · DIN 02292386 · not recorded Auro-Pramipexole · DIN 02424088 · not recorded Mirapex · DIN 02241594 · not recorded Pramipexole · DIN 02309130 · not recorded Pramipexole · DIN 02367610 · not recorded
Shortage status: resolved shortage (ended 2025-04-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02315270
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (28:92 Miscellaneous Central Nervous System Drugs) and how they are covered

Matched class: 28:92 Miscellaneous Central Nervous System Drugs

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: PIZOTYLINE Some products covered without a code (check the product listing): ATOMOXETINE HCL 28:92 Miscellaneous Central Nervous System Drugs

ENTACAPONE

· 4 products · Limited Use, codes 367 · strengths: 200mg · Tab

ATOMOXETINE HCL

· 59 products · Listed, not a benefit (5), General benefit (40), Off-Formulary Interchangeable, not an ODB benefit (14) · strengths: 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg · Cap

PIZOTYLINE

· 1 products · General benefit · strengths: 1mg · Tab

ACAMPROSATE CALCIUM

· 1 products · Limited Use, codes 531 · strengths: 333mg · DR Tab

ALMOTRIPTAN

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 6.25mg, 12.5mg · Tab

DIMETHYL FUMARATE

· 18 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 120mg, 240mg · DR Cap

ELETRIPTAN

· 16 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg, 40mg · Tab

FROVATRIPTAN SUCCINATE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 2.5mg · Tab

MEMANTINE HCL

· 11 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 10mg · Tab

NARATRIPTAN HYDROCHLORIDE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 1mg, 2.5mg · Tab

RIZATRIPTAN

· 44 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mg, 10mg · Orally Disintegrating Tab, Tab

SUMATRIPTAN SUCCINATE

· 37 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 6mg/0.5mL, 25mg, 50mg, 100mg · Inj Sol-Pref Syr 0.5mL Pk, Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 28:92 and 1 more
Full class listing Related classes: 28:08 Analgesics, 28:10 Opiate Antagonists, 28:12 Anticonvulsants, 28:16 Psychotherapeutic Agents, 28:20 C.N.S. Stimulants, 28:24 Sedatives and Hypnotics, 28:36 Antiparkinsonian Agents 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 MIRAPEX (pramipexole dihydrochloride monohydrate) is indicated for adults, as: • treatment of the signs and symptoms of idiopathic Parkinson’s disease. MIRAPEX may be used both as early therapy, without concomitant levodopa, and as an adjunct to levodopa. • symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome. The effectiveness of MIRAPEX used for longer than 12 weeks has not been systematically evaluated in controlled trials for Restless Legs Syndrome. The physician who elects to prescribe MIRAPEX for an extended time should periodically re-evaluate the long-term usefulness for the individual patient. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (> 65 years of age): The majority of pramipexole (88%) is cleared via renal secretion. Due to age-related reduction in renal function, the elderly have a slower clearance of pramipexole (approximately 25 – 30% lower). The efficacy and safety appear to be unaffected, except the relative risk of hallucination is h… https://pdf.hres.ca/dpd_pm/00075012.PDF PM date: MAR 20, 2024 Source product: MIRAPEX; DIN 02237145; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Other review policies

For Sandoz Pramipexole: 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