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

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LEVETIRACETAM

All products: Limited Use (codes 640, 705)

Other products in the same Health Canada class (N03AX) — coverage varies; not interchangeable

  • Lamotrigine (Lamictal): general benefit
  • Topiramate (Topamax Sprinkle): general benefit, Limited Use 321, Not a benefit
  • Brivaracetam (Brivlera): limited Use 548
  • Cenobamate (Xcopri): limited Use 719
  • Lacosamide (Vimpat): limited Use 430
  • Perampanel (Fycompa): limited Use 430, 564

14 more in the class list below

Mint-Levetiracetam Solution · DIN 02558416 · 100mg/mL · Oral Sol

Limited Use — Reason for Use code 640, 705 requiredMarketed · checked 2026-09-20
StatusLimited Use — Reason for Use code 640, 705 required
Write on scriptLU code 640, 705 (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 640, 705
Reason for Use code 640 For patients unable to swallow or tolerate oral solid dosage forms and who are using this as adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory. Coverage limit: LU Authorization Period: 1 year Reason for Use code 705 As adjunctive therapy in the treatment of seizure disorders in pediatric patients (less than 18 years of age) where control by other listed anticonvulsants has been unsatisfactory and where the appropriate dose cannot be achieved using listed solid oral levetiracetam dosage formats. Coverage limit: LU Authorization Period: 1 year
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
Mint-Levetiracetam Solution · DIN 02558416 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2025-10-31 Health Canada: Marketed since 2025-08-14 · brand MINT-LEVETIRACETAM SOLUTION · ATC N03AX14 LEVETIRACETAM · form Solution · route Oral · ingredients LEVETIRACETAM 100 MG/ML · company Mint pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product record

Mint-Levetiracetam Solution: Formulary list price $0.4071/unit (unit not stated in source; not the patient's cost)

Ministry pays: $0.4071 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=106166 · Verify on the e-Formulary ↗ (DIN 02558416)

Source record
DIN 02558416: Mint-Levetiracetam Solution Raw flags: sec12=Y, sec3=Y Item: 281200183; group id 433; item number 1082; lccId 00365; manufacturer id MIN Source form: Oral Sol; strength: 100mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.4071; ministry $0.4071 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02558416 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106166
Interchangeable products
PDP-Levetiracetam · DIN 02490447 · $0.4071 Pharma-Levetiracetam · DIN 02515318 · $0.4071
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (28:12 Anticonvulsants) and how they are covered

Matched class: 28:12 Anticonvulsants

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: CLONAZEPAM, DIVALPROEX SODIUM, ETHOSUXIMIDE, LAMOTRIGINE, VALPROATE SODIUM Some products covered without a code (check the product listing): CARBAMAZEPINE, GABAPENTIN, PHENYTOIN (DIPHENYLHYDANTOIN), PHENYTOIN (DIPHENYLHYDANTOIN) SODIUM, PREGABALIN, PRIMIDONE, TOPIRAMATE, VALPROIC ACID 28:12 Anticonvulsants

LAMOTRIGINE

· 28 products · General benefit · strengths: 25mg, 100mg, 150mg · Tab

TOPIRAMATE

· 54 products · Limited Use, codes 321 (2), Off-Formulary Interchangeable, not an ODB benefit (3), General benefit (49) · strengths: 15mg, 25mg, 50mg, 100mg, 200mg · Sprinkle Cap, Tab

BRIVARACETAM

· 12 products · Limited Use, codes 548 · strengths: 10mg, 25mg, 50mg, 75mg, 100mg · Tab

CENOBAMATE

· 9 products · Limited Use, codes 719 · strengths: 12.5mg, 25mg, 50mg, 100mg, 150mg, 200mg, 12.5mg & 25mg, 50mg & 100mg, 150mg & 200mg · Tab, Tab - (Starter Kit)

LACOSAMIDE

· 44 products · Limited Use, codes 430 · strengths: 50mg, 100mg, 150mg, 200mg · Tab

PERAMPANEL

· 12 products · Limited Use, codes 430, 564 · strengths: 2mg, 4mg, 6mg, 8mg, 10mg, 12mg · Tab

CARBAMAZEPINE

· 15 products · Listed, not a benefit (3), General benefit (6), Temporary benefit (2), Limited Use, codes 67 (4) · strengths: 100mg, 200mg, 400mg, 100mg/5mL · Chew Tab, ER Tab, LA Tab, Oral Susp, Tab

CLONAZEPAM

· 9 products · General benefit · strengths: 0.5mg, 2mg · Tab

DIVALPROEX SODIUM

· 9 products · General benefit · strengths: 125mg, 250mg, 500mg · Ent Tab

ETHOSUXIMIDE

· 4 products · General benefit · strengths: 250mg, 50mg/mL · Cap, O/L

PHENYTOIN (DIPHENYLHYDANTOIN)

· 4 products · General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (2), General benefit (2) · strengths: 6mg/mL, 25mg/mL, 50mg · O/L, Tab

PHENYTOIN (DIPHENYLHYDANTOIN) SODIUM

· 4 products · General benefit (3), Limited Use, codes 481, 657 (1) · strengths: 30mg, 100mg, 50mg/mL · Cap, Inj Sol (Preservative Free) Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 28:12 and 11 more
Full class listing Related classes: 28:08 Analgesics, 28:10 Opiate Antagonists, 28:16 Psychotherapeutic Agents, 28:20 C.N.S. Stimulants, 28:24 Sedatives and Hypnotics, 28:36 Antiparkinsonian Agents, 28:92 Miscellaneous Central Nervous System Drugs 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 KEPPRA (levetiracetam) is indicated as adjunctive therapy in the management of adult (> 18 years of age) patients with epilepsy who are not satisfactorily controlled by conventional therapy. 1.1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of KEPPRA in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use (see 7.1.3 Pediatrics and 10.3 Pharmacokinetics, Special Populations and Conditions, Pediatrics). 1.2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or efficacy (see 7.1.4 Geriatrics, 4.2 Recommended Dose and Dosage Adjustment, Geriatrics and 10.3 Pharmacokinetics, Special Populations and Conditions, Geriatrics). https://pdf.hres.ca/dpd_pm/00069867.PDF PM date: January 21, 2003 Source product: KEPPRA; DIN 02247027; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.