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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 ↗)

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 Manufacturer: Ambicare Pharmaceuticals Inc.; listing date 2026-05-29 Health Canada: Marketed since 2026-03-19 · brand AMB-CYPROTERONE ACETATE / ETHINYL ESTRADIOL · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Ambicare pharmaceuticals inc. · schedule Prescription

DIN 02564424: AMB-Cyproterone Acetate/EthinylEstradiol Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id AMB Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02564424 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106712

Interchangeable products

Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · 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=02564424

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 ↗)

Cleo-35 · DIN 02436736 Manufacturer: Altius Healthcare Inc.; listing date 2024-10-31 Health Canada: Marketed since 2018-05-04 · brand CLÉO -35 · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients ETHINYL ESTRADIOL 0.035 MG, CYPROTERONE ACETATE 2 MG · company Altius healthcare inc · schedule Prescription

DIN 02436736: Cleo-35 Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id ALH Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02436736 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92104

Interchangeable products

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · 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=02436736

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 ↗)

Cyestra-35 · DIN 02290308 Manufacturer: Paladin Labs Inc.; listing date 2007-12-19 Health Canada: Marketed since 2026-02-17 · brand CYESTRA-35 · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Knight therapeutics inc. · schedule Prescription

DIN 02290308: Cyestra-35 Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id PAL Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02290308 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=77558

Interchangeable products

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded

Shortage status: resolved shortage (ended 2026-03-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02290308

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 ↗)

Diane-35 · DIN 02233542 Manufacturer: Bayer Inc., Consumer Care Division; listing date 2007-12-19 Health Canada: Marketed since 2007-12-17 · brand DIANE-35 · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 35 MCG · company Bayer inc · schedule Prescription

DIN 02233542: Diane-35 Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id BAY Source form: Tab-21 Pk; strength: 2mg & 0.035mg 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=02233542 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=53444

Interchangeable products

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · 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=02233542

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 ↗)

Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 Manufacturer: Ranbaxy Pharmaceuticals Canada Inc.; listing date 2015-05-28 Health Canada: Marketed since 2020-08-05 · brand TARO-CYPROTERONE/ETHINYL ESTRADIOL · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Sun pharma canada inc · schedule Prescription

DIN 02425017: Ran-Cyproterone/Ethinyl Estradiol Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id RAN Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3394; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02425017 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90968

Interchangeable products

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 · not recorded

Shortage status: resolved shortage (ended 2026-08-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02425017

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

Teva-Cyproterone/Ethinyl Estradiol · DIN 02309556 Manufacturer: Teva Canada Limited; listing date 2008-12-03 Health Canada: Marketed since 2018-03-08 · brand TEVA-CYPROTERONE / ETHINYL ESTRADIOL · ATC G03HB01 CYPROTERONE AND ESTROGEN · form Tablet · route Oral · ingredients CYPROTERONE ACETATE 2 MG, ETHINYL ESTRADIOL 0.035 MG · company Teva canada limited · schedule Prescription

DIN 02309556: Teva-Cyproterone/Ethinyl Estradiol Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 683200100; group id 792; item number 1929; lccId None; manufacturer id TEV Source form: Tab-21 Pk; strength: 2mg & 0.035mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $23.3400; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02309556 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79517

Interchangeable products

AMB-Cyproterone Acetate/EthinylEstradiol · DIN 02564424 · not recorded Cleo-35 · DIN 02436736 · not recorded Cyestra-35 · DIN 02290308 · not recorded Diane-35 · DIN 02233542 · not recorded Ran-Cyproterone/Ethinyl Estradiol · DIN 02425017 · not recorded

Shortage status: resolved shortage (ended 2023-06-20); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02309556

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