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PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

All products: general benefit

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

  • Entacapone (Comtan): limited Use 367

Pramipexole · DIN 02309122 · 0.25mg · tablet

General benefitMarketed · checked 2026-09-20
StatusGeneral benefit
Write on scriptno code needed
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.
Brand vs generic price
Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)
1 brand, same coverage
Pramipexole · DIN 02309122 Manufacturer: Sivem Pharmaceuticals ULC; listing date 2020-06-30 Health Canada: Marketed since 2018-09-13 · brand PRAMIPEXOLE · ATC N04BC05 PRAMIPEXOLE · form Tablet · route Oral · ingredients PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG · company Sivem pharmaceuticals ulc · schedule Prescription
Check this DIN again · Health Canada product record

Pramipexole: Formulary list price $0.1950/unit (unit not stated in source; not the patient's cost)

Ministry pays: $0.1950 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=79472 · Verify on the e-Formulary ↗ (DIN 02309122)

Source record
DIN 02309122: Pramipexole Raw flags: sec3=Y Item: 289200001; group id 543; item number 1462; lccId None; manufacturer id SIV Source form: Tab; strength: 0.25mg Recorded listing: General benefit Source prices (unrounded): $0.1950; ministry $0.1950 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02309122 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79472
Interchangeable products
Act Pramipexole · DIN 02297302 · $0.1950 Apo-Pramipexole · DIN 02292378 · $0.1950 Auro-Pramipexole · DIN 02424061 · $0.1950 Mirapex · DIN 02237145 · $0.1950 Pramipexole · DIN 02367602 · $0.1950 Sandoz Pramipexole · DIN 02315262 · $0.1950
Shortage status: not checked (no credentials)
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.