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

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LEVODOPA & CARBIDOPA & ENTACAPONE

All strengths: Limited Use — Reason for Use code 367 required; same patient cost rules

Shared coverage and patient cost rules
StatusLimited Use — Reason for Use code 367 required
Patient paysPatient pays: program not supplied; amount cannot be determined.

Other products in the same Health Canada class (N04B, N04BA) — coverage varies; not interchangeable

  • Benserazide + levodopa (Prolopa 50-12.5): general benefit
  • Carbidopa + levodopa (Sinemet CR): general benefit, Limited Use, Not a benefit
  • Amantadine (Symmetrel): general benefit, Not a benefit
  • Bromocriptine (Parlodel): general benefit, Not a benefit
  • Ropinirole (ReQuip): general benefit, Not a benefit
  • Selegiline (Eldepryl): general benefit, Not a benefit

Stalevo · DIN 02305933 · 50 & 12.5 & 200mg · tablet

Limited Use — Reason for Use code 367 requiredMarketed · checked 2026-09-02
Write on scriptLU code 367 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 367
Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Stalevo · DIN 02305933 Manufacturer: Sandoz Canada Inc.; listing date 2009-03-02 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients ENTACAPONE 200 MG, LEVODOPA 50 MG, CARBIDOPA 12.5 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Stalevo: Formulary list price $1.7471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.7471 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=79150 · Verify on the e-Formulary ↗ (DIN 02305933)

Source record
DIN 02305933: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000588; group id 932; item number 2224; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 50 & 12.5 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02305933 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79150
Shortage status: resolved shortage (ended 2021-03-12); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02305933
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Stalevo · DIN 02337827 · 75 & 18.75 & 200mg · tablet

Limited Use — Reason for Use code 367 requiredMarketed · checked 2026-09-02
Write on scriptLU code 367 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 367
Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Stalevo · DIN 02337827 Manufacturer: Sandoz Canada Inc.; listing date 2010-10-28 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients CARBIDOPA 18.75 MG, ENTACAPONE 200 MG, LEVODOPA 75 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Stalevo: Formulary list price $1.7471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.7471 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=82347 · Verify on the e-Formulary ↗ (DIN 02337827)

Source record
DIN 02337827: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000615; group id 932; item number 2222; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 75 & 18.75 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02337827 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=82347
Shortage status: resolved shortage (ended 2021-04-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02337827
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Stalevo · DIN 02305941 · 100 & 25 & 200mg · tablet

Limited Use — Reason for Use code 367 requiredMarketed · checked 2026-09-02
Write on scriptLU code 367 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 367
Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Stalevo · DIN 02305941 Manufacturer: Sandoz Canada Inc.; listing date 2009-03-02 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients CARBIDOPA 25 MG, LEVODOPA 100 MG, ENTACAPONE 200 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Stalevo: Formulary list price $1.7471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.7471 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=79151 · Verify on the e-Formulary ↗ (DIN 02305941)

Source record
DIN 02305941: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000589; group id 932; item number 2225; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 100 & 25 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02305941 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79151
Shortage status: resolved shortage (ended 2024-07-08); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02305941
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Stalevo · DIN 02337835 · 125 & 31.25 & 200mg · tablet

Limited Use — Reason for Use code 367 requiredMarketed · checked 2026-09-02
Write on scriptLU code 367 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 367
Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Stalevo · DIN 02337835 Manufacturer: Sandoz Canada Inc.; listing date 2010-10-28 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients ENTACAPONE 200 MG, LEVODOPA 125 MG, CARBIDOPA 31.25 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Stalevo: Formulary list price $1.7471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.7471 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=82348 · Verify on the e-Formulary ↗ (DIN 02337835)

Source record
DIN 02337835: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000616; group id 932; item number 2223; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 125 & 31.25 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02337835 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=82348
Shortage status: resolved shortage (ended 2021-03-12); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02337835
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Stalevo · DIN 02305968 · 150 & 37.5 & 200mg · tablet

Limited Use — Reason for Use code 367 requiredMarketed · checked 2026-09-02
Write on scriptLU code 367 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 367
Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Stalevo · DIN 02305968 Manufacturer: Sandoz Canada Inc.; listing date 2009-03-02 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients CARBIDOPA 37.5 MG, ENTACAPONE 200 MG, LEVODOPA 150 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Stalevo: Formulary list price $1.7471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $1.7471 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=79152 · Verify on the e-Formulary ↗ (DIN 02305968)

Source record
DIN 02305968: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000590; group id 932; item number 2226; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 150 & 37.5 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02305968 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79152
Shortage status: resolved shortage (ended 2024-07-29); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02305968
Shortage record checked 2026-09-13T08:10:21.292534+00:00
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

LEVODOPA & BENSERAZIDE

· 3 products · General benefit · strengths: 50mg & 12.5mg, 100mg & 25mg, 200mg & 50mg · Cap

LEVODOPA & CARBIDOPA

· 25 products · Listed, not a benefit (5), Limited Use, codes 64, 65 (2), General benefit (18) · strengths: 100mg & 25mg, 200mg & 50mg, 100mg & 10mg, 250mg & 25mg · CR Tab, Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

ROPINIROLE

· 12 products · Listed, not a benefit (4), General benefit (8) · strengths: 0.25mg, 1mg, 2mg, 5mg · Tab

SELEGILINE HCL

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 5mg · Tab

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AZATHIOPRINE

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

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L 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 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE STALEVO® (levodopa, carbidopa and entacapone) is indicated to treat patients with idiopathic Parkinson’s disease: • To substitute for immediate-release levodopa/carbidopa and entacapone previously administered as individual products. • To replace immediate-release levodopa/carbidopa therapy (without entacapone) when patients experience the signs and symptoms of end of dose "wearing off" (only recommended when patients are taking a total daily dose of levodopa of 600 mg or less and not experiencing dyskinesias, see DOSAGE AND ADMINISTRATION). Geriatrics: No adjustment of STALEVO dosage is necessary in elderly patients. Pediatrics (< 18 years of age): Safety and effectiveness in pediatric patients have not been established. STALEVO is not indicated for use in children under 18 years of age. https://pdf.hres.ca/dpd_pm/00057237.PDF PM date: July 21, 2020 Source product: STALEVO; DIN 02305933; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.