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

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BOTULINUM TOXIN TYPE A

All injection strengths: Limited Use (codes 10, 130, 412, 413, 440, 460)

Other products in the same Health Canada class (M03AX) — coverage varies; not interchangeable

  • Abobotulinum toxin a (Dysport Therapeutic): limited Use 130, 412, 413
  • Incobotulinumtoxina (Xeomin): limited Use 130, 412, 421

Botox · DIN 02531585 · 200U/Vial · Pd injection-200U vial

Limited Use — Reason for Use code 10, 130, 412, 413, 440, 460 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 10, 130, 412, 413, 440, 460 required
Write on scriptLU code 10, 130, 412, 413, 440, 460 (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 10, 130, 412, 413, 440, 460
Reason for Use code 10 For the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older. Coverage limit: LU Authorization Period: 1 year Reason for Use code 130 To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults. Coverage limit: LU Authorization Period: 1 year Reason for Use code 412 For the management of focal spasticity, due to stroke or spinal cord injury in adults. Coverage limit: LU Authorization Period: 1 year Reason for Use code 413 For the treatment of focal spasticity secondary to cerebral palsy in patients two years of age or older. Coverage limit: LU Authorization Period: 1 year Reason for Use code 440 For adult patients with urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury who fail to respond to behavioural medication and anticholinergics and/or are intolerant to anticholinergics. The recommended dose is 200U injected into the detrusor muscle. Subsequent injections should be provided at intervals of no less than every 36 weeks and patients who fail to respond to initial treatment with Botulinum Toxin Type A should not be retreated. Coverage limit: LU Authorization Period: 1 year Reason for Use code 460 For adult patients with urinary frequency, urgency or urge incontinence due to overactive bladder who have: Failed to respond to behavioral techniques AND had an inadequate response or intolerance to adequate trials (i.e., at least 2 weeks at the maximum tolerated dose) of at least two medications for overactive bladder (e.g. anticholinergics, mirabegron). The recommended dose is 100U injected into the detrusor muscle. NOTES: -Patients who fail to achieve a reduction of greater than 50 percent in the frequency of urinary incontinence episodes with 1 dose should not be retreated. -Maximum 3 doses per year in responders, at a frequency of no more than once every 12 weeks. -Patients must have a post-void residual (PVR) urine volume of less than 150mL. Coverage limit: LU Authorization Period: 1 year Coverage limit: Note: Botox should be administered personally by a urologist, pediatrician, neurologist, physical medicine specialist or a physician with equivalent post-graduate training and experience with neuromuscular or urological disorders as appropriate.
No interchangeable product listed in the Ontario extract
Botox · DIN 02531585 Manufacturer: AbbVie Corporation; listing date 2023-10-31 Health Canada: Marketed since 2023-10-11 · brand BOTOX · ATC M03AX01 BOTULINUM TOXIN · form Powder for solution · route Intradetrusorial, Intramuscular, Intradermal · ingredients ONABOTULINUMTOXINA 200 UNIT/VIAL · company Abbvie corporation · schedule Schedule d, Prescription
Check this DIN again · Health Canada product record

Botox: Formulary list price $779.6880/unit (unit not stated in source; not the patient's cost)

Ministry pays: $779.6880 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=102070 · Verify on the e-Formulary ↗ (DIN 02531585)

Source record
DIN 02531585: Botox Raw flags: sec12=Y, sec3=Y Item: 920000745; group id 899; item number 2155; lccId 00122; manufacturer id ABV Source form: Pd Inj-200U Vial Pk; strength: 200U/Vial Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $779.6880; ministry $779.6880 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02531585 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102070
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02531585
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

INCOBOTULINUMTOXINA

· 3 products · Limited Use, codes 130, 412, 421 · strengths: 50 LD50 Units, 100 LD50 Units, 200 Units/Vial · Pd for Inj-Vial Pk, Pd for Inj-Vial Pk (Preservative-Free)

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

AMANTADINE HCL

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

AZATHIOPRINE

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

BROMOCRIPTINE

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

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab 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
1 INDICATIONS BOTOX® (onabotulinumtoxinA for injection) is indicated for: Blepharospasm • for the treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older, Strabismus • for the treatment of strabismus in patients 12 years of age or older. Botox is ineffective in chronic paralytic strabismus except to reduce antagonist contracture in conjunction with surgical repair, Cervical Dystonia (spasmodic torticollis) • to reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults, Focal Spasticity • in the management of focal spasticity, including the treatment of upper limb spasticity in adults, • for the symptomatic treatment of lower limb spasticity in adults, • for symptomatic treatment of upper and/or lower limb spasticity in pediatric patients two years of age or older, Botox is not intended as a replacement for usual standard of care regimens and is not likely to be effective in improving range of motion at a joint affected by a fixed contracture. Primary Hyperhidrosis of the Axillae • for the treatment of hyper… https://pdf.hres.ca/dpd_pm/00078815.PDF PM date: March 10, 2025 Source product: BOTOX; DIN 01981501; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.