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Exceptional Access criteria on record are for Brand(s): Nitoman; DOSAGE FORM/ STRENGTH: 25 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet For the treatment of Hungtington’s chorea, tic and Gille’s de la Toureet syndrome and tardive dyskinesia in patients meeting the following criteria: i) is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND ii) have disabling Huntington’s chorea OR tic and Gille’s de la Tourette syndrome and have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. **Note that for patients with disabling tardive dyskinesia, a trial of a Formulary agent is NOT required (i.e. tetrabenazine can be considered for use as a first-line agent) Duration of Approval: 1 year Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. Duration of Approval: 5 years For the treatment of Hemiballismus, senile chorea, or other disabling hyperkinetic movement disorders (HKMD) will be considered on a case-by-case basis in patients meeting the following criteria: • is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND • have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. Duration of Approval: 1 year Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND 106 Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. Duration of Approval: 5 years Please note that information MUST BE provided about why a patient has not tried or cannot try a formulary alternative. Requests not meeting the above criteria for HKMD will be considered through a case-by-case review and the physician must provide adequate clinical information to enable this assessment. 107  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 106, record 66, corpus 2025-01-01; name match only, not an eligibility decision

Apo-Tetrabenazine · DIN 02407590 Manufacturer: Apotex Inc.; listing date 2013-11-28 Health Canada: Marketed since 2013-11-01 · brand APO-TETRABENAZINE · ATC N07XX06 TETRABENAZINE · form Tablet · route Oral · ingredients TETRABENAZINE 25 MG · company Apotex inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02407590). DIN 02407590: Apo-Tetrabenazine Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000447; group id 968; item number 2298; lccId None; manufacturer id APX Source form: Tab; strength: 25mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $4.8551; ministry $4.8551 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02407590 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89232

Interchangeable products

Nitoman · DIN 02199270 · not recorded PMS-Tetrabenazine · DIN 02402424 · $4.8551 Tetrabenazine Tablets · DIN 02410338 · $4.8551

Shortage status: active shortage (reported 2026-09-08, estimated to end 2026-10-02, last updated 2026-09-11); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02407590

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet For the treatment of Hungtington’s chorea, tic and Gille’s de la Toureet syndrome and tardive dyskinesia in patients meeting the following criteria: i) is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND ii) have disabling Huntington’s chorea OR tic and Gille’s de la Tourette syndrome and have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. **Note that for patients with disabling tardive dyskinesia, a trial of a Formulary agent is NOT required (i.e. tetrabenazine can be considered for use as a first-line agent) Duration of Approval: 1 year Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. Duration of Approval: 5 years For the treatment of Hemiballismus, senile chorea, or other disabling hyperkinetic movement disorders (HKMD) will be considered on a case-by-case basis in patients meeting the following criteria: • is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND • have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. Duration of Approval: 1 year Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND 106 Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. Duration of Approval: 5 years Please note that information MUST BE provided about why a patient has not tried or cannot try a formulary alternative. Requests not meeting the above criteria for HKMD will be considered through a case-by-case review and the physician must provide adequate clinical information to enable this assessment. 107  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 106, record 66, corpus 2025-01-01; name match only, not an eligibility decision

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Nitoman · DIN 02199270 Manufacturer: Valeant Canada Ltd.; listing date 2013-04-30 Health Canada: Marketed since 2020-10-02 · brand NITOMAN · ATC N07XX06 TETRABENAZINE · form Tablet · route Oral · ingredients TETRABENAZINE 25 MG · company Bausch health, canada inc. · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02199270). DIN 02199270: Nitoman Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000447; group id 968; item number 2298; lccId None; manufacturer id VAL Source form: Tab; strength: 25mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02199270 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=42959

Interchangeable products

Apo-Tetrabenazine · DIN 02407590 · $4.8551 PMS-Tetrabenazine · DIN 02402424 · $4.8551 Tetrabenazine Tablets · DIN 02410338 · $4.8551

Shortage status: resolved shortage (ended 2022-05-17); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02199270

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access criteria on record are for Brand(s): Nitoman; DOSAGE FORM/ STRENGTH: 25 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet For the treatment of Hungtington’s chorea, tic and Gille’s de la Toureet syndrome and tardive dyskinesia in patients meeting the following criteria: i) is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND ii) have disabling Huntington’s chorea OR tic and Gille’s de la Tourette syndrome and have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. **Note that for patients with disabling tardive dyskinesia, a trial of a Formulary agent is NOT required (i.e. tetrabenazine can be considered for use as a first-line agent) Duration of Approval: 1 year Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. Duration of Approval: 5 years For the treatment of Hemiballismus, senile chorea, or other disabling hyperkinetic movement disorders (HKMD) will be considered on a case-by-case basis in patients meeting the following criteria: • is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND • have documented evidence of failure to respond, intolerable side effects or contraindication to at least one agent presently available on the Formulary. Duration of Approval: 1 year Renewals will be considered for patients whose request is prescribed by (or in consultation with) physicians who are experienced in the treatment of hyperkinetic movement disorders (e.g. specialists practicing in a Movement Disorder Clinic, neurologists, psychiatrists, physiatrists, geriatricians, pediatricians); AND 106 Tetrabenazine Brand(s): Nitoman DOSAGE FORM/ STRENGTH: 25 mg tablet who provide written confirmation that movements and functional status are stabilized on tetrabenazine therapy. Duration of Approval: 5 years Please note that information MUST BE provided about why a patient has not tried or cannot try a formulary alternative. Requests not meeting the above criteria for HKMD will be considered through a case-by-case review and the physician must provide adequate clinical information to enable this assessment. 107  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 106, record 66, corpus 2025-01-01; name match only, not an eligibility decision

PMS-Tetrabenazine · DIN 02402424 Manufacturer: Pharmascience Inc.; listing date 2013-04-30 Health Canada: Marketed since 2013-02-26 · brand PMS-TETRABENAZINE · ATC N07XX06 TETRABENAZINE · form Tablet · route Oral · ingredients TETRABENAZINE 25 MG · company Pharmascience inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02402424). DIN 02402424: PMS-Tetrabenazine Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000447; group id 968; item number 2298; lccId None; manufacturer id PMS Source form: Tab; strength: 25mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $4.8551; ministry $4.8551 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02402424 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88726

Interchangeable products

Apo-Tetrabenazine · DIN 02407590 · $4.8551 Nitoman · DIN 02199270 · not recorded Tetrabenazine Tablets · DIN 02410338 · $4.8551

Shortage status: resolved shortage (ended 2019-10-31); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02402424

Shortage record checked 2026-09-13T08:10:21.292534+00:00