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Blexten · DIN 02519011 Manufacturer: Aralez Pharmaceuticals Canada Inc.; listing date 2026-03-31 Health Canada: Marketed since 2022-02-10 · brand BLEXTEN · ATC R06AX29 BILASTINE · form Solution · route Oral · ingredients BILASTINE 2.5 MG/ML · company Aralez pharmaceuticals canada inc · schedule Prescription

DIN 02519011: Blexten Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000091; group id 1; item number 0001; lccId None; manufacturer id ARZ Source form: Oral Sol; strength: 2.5mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02519011 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100830

Interchangeable products

Jamp Bilastine Oral Solution · DIN 02448262 · not recorded

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=02519011

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

Jamp Bilastine Oral Solution · DIN 02448262 Manufacturer: Jamp Pharma Corporation; listing date 2026-03-31 Health Canada: Marketed since 2026-04-21 · brand JAMP BILASTINE ORAL SOLUTION · ATC not recorded · form Solution · route Oral · ingredients BILASTINE 2.5 MG/ML · company Jamp pharma corporation · schedule Prescription

DIN 02448262: Jamp Bilastine Oral Solution Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000091; group id 1; item number 0001; lccId None; manufacturer id JPC Source form: Oral Sol; strength: 2.5mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $0.1626; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02448262 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93393

Interchangeable products

Blexten · DIN 02519011 · not recorded

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=02448262

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

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 ↗)

Apo-Bilastine Tablets · DIN 02549883 Manufacturer: Apotex Inc.; listing date 2024-12-30 Health Canada: Marketed since 2024-10-29 · brand APO-BILASTINE TABLETS · ATC R06AX OTHER ANTIHISTAMINES FOR SYSTEMIC USE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Apotex inc · schedule Prescription

DIN 02549883: Apo-Bilastine Tablets Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id APX Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1240; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02549883 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103870

Interchangeable products

Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

Shortage status: resolved shortage (ended 2025-04-10); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02549883

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

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 ↗)

Auro-Bilastine · DIN 02541556 Manufacturer: Auro Pharma Inc.; listing date 2025-01-31 Health Canada: Marketed since 2024-10-25 · brand AURO-BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Auro pharma inc · schedule Prescription

DIN 02541556: Auro-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id AUR Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1229; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02541556 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103019

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02541556

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

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 ↗)

Blexten · DIN 02454130 Manufacturer: Aralez Pharmaceuticals Canada Inc.; listing date 2024-12-30 Health Canada: Marketed since 2019-05-30 · brand BLEXTEN · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Aralez pharmaceuticals canada inc · schedule Prescription

DIN 02454130: Blexten Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id ARZ Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02454130 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94066

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02454130

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

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 ↗)

GLN-Bilastine · DIN 02544369 Manufacturer: Glenmark Pharmaceuticals Canada Inc.; listing date 2024-12-30 Health Canada: Marketed since 2024-10-22 · brand GLN-BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Glenmark pharmaceuticals canada inc. · schedule Prescription

DIN 02544369: GLN-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id GLP Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1243; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02544369 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103292

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

Shortage status: active shortage (reported not recorded, last updated 2026-06-08); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02544369

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

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 ↗)

Jamp-Bilastine · DIN 02546795 Manufacturer: Jamp Pharma Corporation; listing date 2024-12-30 Health Canada: Marketed since 2024-10-22 · brand JAMP BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Jamp pharma corporation · schedule Prescription

DIN 02546795: Jamp-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id JPC Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1240; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02546795 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103547

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02546795

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

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 ↗)

M-Bilastine · DIN 02548410 Manufacturer: Mantra Pharma Inc.; listing date 2024-12-30 Health Canada: Marketed since 2024-10-24 · brand M-BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Mantra pharma inc · schedule Prescription

DIN 02548410: M-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id MAT Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1240; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02548410 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103730

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02548410

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

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 ↗)

Mar-Bilastine · DIN 02547279 Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2024-12-30 Health Canada: Marketed since 2024-10-22 · brand MAR-BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Marcan pharmaceuticals inc · schedule Prescription

DIN 02547279: Mar-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id MAR Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1240; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02547279 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103590

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02547279

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

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 ↗)

NRA-Bilastine · DIN 02551934 Manufacturer: Nora Pharma; listing date 2024-12-30 Health Canada: Marketed since 2024-10-30 · brand NRA-BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Nora pharma inc · schedule Prescription

DIN 02551934: NRA-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id NRA Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1243; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02551934 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=104063

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded PMS-Bilastine · DIN 02561565 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02551934

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

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 ↗)

PMS-Bilastine · DIN 02561565 Manufacturer: Pharmascience Inc.; listing date 2026-06-30 Health Canada: Marketed since 2026-04-30 · brand PMS-BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE 20 MG · company Pharmascience inc · schedule Prescription

DIN 02561565: PMS-Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id PMS Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1240; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02561565 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106452

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded Sandoz Bilastine · DIN 02536269 · not recorded

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=02561565

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

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 ↗)

Sandoz Bilastine · DIN 02536269 Manufacturer: Sandoz Canada Inc.; listing date 2024-12-30 Health Canada: Marketed since 2024-10-22 · brand SANDOZ BILASTINE · ATC R06AX29 BILASTINE · form Tablet · route Oral · ingredients BILASTINE (BILASTINE MONOHYDRATE) 20 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02536269: Sandoz Bilastine Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 040000089; group id 1; item number 0002; lccId None; manufacturer id SDZ Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $1.1240; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02536269 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102505

Interchangeable products

Apo-Bilastine Tablets · DIN 02549883 · not recorded Auro-Bilastine · DIN 02541556 · not recorded Blexten · DIN 02454130 · not recorded GLN-Bilastine · DIN 02544369 · not recorded Jamp-Bilastine · DIN 02546795 · not recorded M-Bilastine · DIN 02548410 · not recorded Mar-Bilastine · DIN 02547279 · not recorded NRA-Bilastine · DIN 02551934 · not recorded PMS-Bilastine · DIN 02561565 · not recorded

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=02536269

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