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Reason for Use code 687 To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 688 To increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Stoboclo · DIN 02560917 Manufacturer: Celltrion Inc.; listing date 2025-11-28 Health Canada: Marketed since 2025-10-30 · brand STOBOCLO · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 60 MG/ML · company Celltrion inc. · schedule Schedule d, Prescription

DIN 02560917: Stoboclo Raw flags: sec12=Y, sec3=Y Item: 920000804; group id 909; item number 2176; lccId 00397; manufacturer id CEI Source form: Inj Sol-1.0mL Pref Syr Pk (Preservative-Free); strength: 60mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $194.7000; ministry $194.7000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02560917 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106393

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=02560917

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

Reason for Use code 687 To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 688 To increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Jubbonti (Preservative Free) · DIN 02545411 Manufacturer: Sandoz Canada Inc.; listing date 2024-08-30 Health Canada: Marketed since 2024-07-25 · brand JUBBONTI · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 60 MG/ML · company Sandoz canada incorporated · schedule Schedule d, Prescription

DIN 02545411: Jubbonti (Preservative Free) Raw flags: sec12=Y, sec3=Y Item: 920000786; group id 909; item number 2177; lccId 00397; manufacturer id SDZ Source form: Inj Sol-Pref Syr; strength: 60mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $181.0700; ministry $181.0700 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02545411 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103418

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=02545411

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

Reason for Use code 687 To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 688 To increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Bildyos · DIN 02565951 Manufacturer: Shanghai Henlius Biotech, Inc.; listing date 2026-08-31 Health Canada: Marketed since 2026-05-19 · brand BILDYOS · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 60 MG/ML · company Shanghai henlius biotech, inc. · schedule Schedule d, Prescription

DIN 02565951: Bildyos Raw flags: sec12=Y, sec3=Y Item: 920000823; group id 909; item number 2178; lccId 00397; manufacturer id SHA Source form: Inj Sol-Pref Syr (Preservative-Free); strength: 60mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $181.0710; ministry $181.0710 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02565951 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106851

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=02565951

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

Reason for Use code 687 To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 688 To increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool. Coverage limit: LU Authorization Period: Indefinite Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Denoza · DIN 02566265 Manufacturer: Apotex Inc.; listing date 2026-08-31 Health Canada: Marketed since 2026-08-24 · brand DENOZA · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 60 MG/ML · company Apotex inc · schedule Prescription, Schedule d

DIN 02566265: Denoza Raw flags: sec12=Y, sec3=Y Item: 920000824; group id 909; item number 2179; lccId 00397; manufacturer id APX Source form: Inj Sol-Pref Syr (Preservative-Free); strength: 60mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $181.0710; ministry $181.0710 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02566265 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106879

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=02566265

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

Reason for Use code 686 For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease, despite castrate serum testosterone levels (less than 1.7nmol/L or less than 50ng/dL) or having undergone orchidectomy. Dose: 120mg SC every 4 weeks Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Wyost (Preservative Free) · DIN 02545764 Manufacturer: Sandoz Canada Inc.; listing date 2024-08-30 Health Canada: Marketed since 2024-06-26 · brand WYOST · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 120 MG/1.7ML · company Sandoz canada incorporated · schedule Prescription, Schedule d

DIN 02545764: Wyost (Preservative Free) Raw flags: sec12=Y, sec3=Y Item: 920000787; group id 910; item number 2180; lccId 00398; manufacturer id SDZ Source form: Inj Sol-Vial Pk; strength: 120mg/1.7mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $290.1600; ministry $290.1600 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02545764 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103450

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=02545764

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

Reason for Use code 686 For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease, despite castrate serum testosterone levels (less than 1.7nmol/L or less than 50ng/dL) or having undergone orchidectomy. Dose: 120mg SC every 4 weeks Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Osenvelt · DIN 02560895 Manufacturer: Celltrion Inc.; listing date 2025-11-28 Health Canada: Marketed since 2025-10-30 · brand OSENVELT · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 120 MG/1.7ML · company Celltrion inc. · schedule Schedule d, Prescription

DIN 02560895: Osenvelt Raw flags: sec12=Y, sec3=Y Item: 920000800; group id 910; item number 2181; lccId 00398; manufacturer id CEI Source form: Inj Sol-Vial Pk (Preservative-Free); strength: 120mg/1.7mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $312.0000; ministry $312.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02560895 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106391

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=02560895

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

Reason for Use code 686 For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease, despite castrate serum testosterone levels (less than 1.7nmol/L or less than 50ng/dL) or having undergone orchidectomy. Dose: 120mg SC every 4 weeks Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Tuzemty · DIN 02566001 Manufacturer: Shanghai Henlius Biotech, Inc.; listing date 2026-08-31 Health Canada: Marketed since 2026-05-19 · brand TUZEMTY · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 120 MG/1.7ML · company Shanghai henlius biotech, inc. · schedule Schedule d, Prescription

DIN 02566001: Tuzemty Raw flags: sec12=Y, sec3=Y Item: 920000826; group id 910; item number 2183; lccId 00398; manufacturer id SHA Source form: Inj Sol-Vial Pk (Preservative-Free); strength: 120mg/1.7mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $290.1600; ministry $290.1600 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02566001 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106855

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=02566001

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

Reason for Use code 686 For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease, despite castrate serum testosterone levels (less than 1.7nmol/L or less than 50ng/dL) or having undergone orchidectomy. Dose: 120mg SC every 4 weeks Coverage limit: LU Authorization Period: 1 year Exceptional Access criteria on record are for Brand(s): Xgeva; DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection — 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 Denosumab Brand(s): Xgeva DOSAGE FORM/ STRENGTH: 120 mg per vial for subcutaneous injection Updated September 11. 2024 Originator Xgeva will only be considered in patients who are established on Xgeva therapy who meet a medically necessary exemption. For the treatment of bony metastases in patients with hormone refractory prostate cancer. Xgeva is considered through CCO for those receiving prostate cancer treatment from a cancer clinic. Hormone refractory prostate cancer is determined using the following criteria: i) Patient has an elevated PSA level or evidence of progressive bony disease1, despite castrate serum testosterone levels (Less than 1.7 nmol/L or less than 50 ng/dL)2. 1 Progressive bony disease is defined as progressive changes in radionucleotide bone scan or clinical signs of disease profession, such as pathologic fracture or increasing bone pain. 2 Note: Patients who have undergone orchidectomy do not need to provide a serum testosterone level in the request submission. Approved Dosing. 120 mg subcutaneously every four (4) weeks Duration of Approval: 1 Year Renewals will be considered for patient responding to treatment with Xgeva and who still requires treatment. Duration of Approval: 1 Year 392 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 392, record 225, corpus 2025-01-01; name match only, not an eligibility decision

Idenos · DIN 02566273 Manufacturer: Apotex Inc.; listing date 2026-08-31 Health Canada: Approved since 2026-03-11 · brand IDENOS · ATC M05BX04 DENOSUMAB · form Solution · route Subcutaneous · ingredients DENOSUMAB 120 MG/1.7ML · company Apotex inc · schedule Schedule d, Prescription

DIN 02566273: Idenos Raw flags: sec12=Y, sec3=Y Item: 920000825; group id 910; item number 2182; lccId 00398; manufacturer id APX Source form: Inj Sol-Vial Pk (Preservative-Free); strength: 120mg/1.7mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $290.1600; ministry $290.1600 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02566273 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106880

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=02566273

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

Health Canada lists this DIN as Approved since 2026-03-11 — choose a marketed DIN from the same-category list.