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Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

Jamp Posaconazole · DIN 02530333 Manufacturer: Jamp Pharma Corporation; listing date 2023-03-31 Health Canada: Marketed since 2023-05-24 · brand JAMP POSACONAZOLE · ATC J02AC04 POSACONAZOLE · form Suspension · route Oral · ingredients POSACONAZOLE 40 MG/ML · company Jamp pharma corporation · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02530333). DIN 02530333: Jamp Posaconazole Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204037; group id 15; item number 0020; lccId None; manufacturer id JPC Source form: O/L; strength: 40mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $8.2765; ministry $8.2765 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02530333 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101953

Interchangeable products

Posanol · DIN 02293404 · $8.2765

Shortage status: resolved shortage (ended 2024-05-09); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02530333

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

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

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

Posanol · DIN 02293404 Manufacturer: Schering-Plough Canada Inc.; listing date 2023-03-31 Health Canada: Marketed since 2011-03-18 · brand POSANOL · ATC J02AC04 POSACONAZOLE · form Suspension · route Oral · ingredients POSACONAZOLE 200 MG/5ML · company Merck canada inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02293404). DIN 02293404: Posanol Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204037; group id 15; item number 0020; lccId None; manufacturer id SCP Source form: O/L; strength: 40mg/mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $10.1801; ministry $8.2765 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02293404 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=77877

Interchangeable products

Jamp Posaconazole · DIN 02530333 · $8.2765

Shortage status: To be discontinued; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02293404

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

Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

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-Posaconazole · DIN 02542021 Manufacturer: Glenmark Pharmaceuticals Canada Inc.; listing date 2023-11-30 Health Canada: Marketed since 2023-10-04 · brand GLN-POSACONAZOLE · ATC J02AC04 POSACONAZOLE · form Tablet (delayed-release) · route Oral · ingredients POSACONAZOLE 100 MG · company Glenmark pharmaceuticals canada inc. · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02542021). DIN 02542021: GLN-Posaconazole Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204038; group id 15; item number 0019; lccId None; manufacturer id GLP Source form: DR Tab; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $42.6030; ministry $42.6030 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02542021 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103062

Interchangeable products

Mint-Posaconazole · DIN 02544644 · $42.6030 Posanol · DIN 02424622 · $42.6030 Sandoz Posaconazole · DIN 02496259 · $42.6030 Taro-Posaconazole · DIN 02543311 · $42.6030

Shortage status: resolved shortage (ended 2026-04-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02542021

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

Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

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 ↗)

Mint-Posaconazole · DIN 02544644 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2024-08-30 Health Canada: Marketed since 2024-07-25 · brand MINT-POSACONAZOLE · ATC J02AC04 POSACONAZOLE · form Tablet (delayed-release) · route Oral · ingredients POSACONAZOLE 100 MG · company Mint pharmaceuticals inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02544644). DIN 02544644: Mint-Posaconazole Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204038; group id 15; item number 0019; lccId None; manufacturer id MIN Source form: DR Tab; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $42.6030; ministry $42.6030 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02544644 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103321

Interchangeable products

GLN-Posaconazole · DIN 02542021 · $42.6030 Posanol · DIN 02424622 · $42.6030 Sandoz Posaconazole · DIN 02496259 · $42.6030 Taro-Posaconazole · DIN 02543311 · $42.6030

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=02544644

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

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

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

Posanol · DIN 02424622 Manufacturer: Merck Canada Inc.; listing date 2021-01-29 Health Canada: Marketed since 2014-05-21 · brand POSANOL · ATC J02AC04 POSACONAZOLE · form Tablet (delayed-release) · route Oral · ingredients POSACONAZOLE 100 MG · company Merck canada inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02424622). DIN 02424622: Posanol Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204038; group id 15; item number 0019; lccId None; manufacturer id MEK Source form: DR Tab; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $53.7642; ministry $42.6030 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02424622 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90930

Interchangeable products

GLN-Posaconazole · DIN 02542021 · $42.6030 Mint-Posaconazole · DIN 02544644 · $42.6030 Sandoz Posaconazole · DIN 02496259 · $42.6030 Taro-Posaconazole · DIN 02543311 · $42.6030

Shortage status: resolved shortage (ended 2024-06-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02424622

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

Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

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 Posaconazole · DIN 02496259 Manufacturer: Sandoz Canada Inc.; listing date 2021-01-29 Health Canada: Marketed since 2020-12-08 · brand SANDOZ POSACONAZOLE · ATC J02AC04 POSACONAZOLE · form Tablet (delayed-release) · route Oral · ingredients POSACONAZOLE 100 MG · company Sandoz canada incorporated · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02496259). DIN 02496259: Sandoz Posaconazole Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204038; group id 15; item number 0019; lccId None; manufacturer id SDZ Source form: DR Tab; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $42.6030; ministry $42.6030 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02496259 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98612

Interchangeable products

GLN-Posaconazole · DIN 02542021 · $42.6030 Mint-Posaconazole · DIN 02544644 · $42.6030 Posanol · DIN 02424622 · $42.6030 Taro-Posaconazole · DIN 02543311 · $42.6030

Shortage status: resolved shortage (ended 2026-03-09); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02496259

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

Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. Duration of Approval: Limited to 4 months For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case-by-case basis. Note: Please provide details of the patient’s clinical condition including all medications used to treat the condition with your request application. Duration of Approval: Up to 4 months Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. Duration of Approval: Case-by-case For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered on a case-by-case basis. 49 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 100 mg tablet, 40 mg/mL Suspension For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR Duration of Approval: 3 months For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Duration of Approval: 3 months Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information ( Infectious disease consultation/radiology report) Duration of Approval: 3 months Duration of Approval of subsequent renewal: Case-by-case EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 49, record 27, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Posanol; DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets — 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 Posaconazole Brand(s): Posanol DOSAGE FORM/ STRENGTH: 40 mg/mL Suspension, 100 mg tablets 1. For the prophylaxis of Aspergillus and Candida infections in patients who have recently (within the past 3 months) undergone an allogeneic bone marrow transplant. 2. For the prophylaxis of invasive fungal infections in patients who have previously (3 months or longer) undergone an allogeneic stem cell transplant and are experiencing moderate to severe graft-versus-host-disease (GVHD) will be considered on a case- by-case basis. Renewals will be considered on a case-by-case basis for patients who continue to experience ongoing symptoms of moderate to severe GVHD. Please provide information regarding infections that were experienced while on therapy (as applicable) including the names of medications and treatments being used to manage GVHD. 3. For the treatment of invasive aspergillosis* in patients who are refractory or intolerant to voriconazole OR who have documented contraindication to voriconazole. *Invasive aspergillosis should be confirmed by fungal culture. Note: Requests without a positive fungal culture must be accompanied by a consultation note from an infectious disease expert with details of how the diagnosis was made and will be considered on a case-by-case basis. Renewals will be considered on a case-by-case basis. 4. For the treatment of mucormycosis** in patients who have failed, have a contraindication to, or experienced intolerance to amphotericin B; OR For the step-down treatment of mucormycosis** in patients who have been initially treated with amphotericin B but cannot tolerate long-term therapy with this agent. **Mucormycosis infection must be confirmed by fungal culture. Note: Requests without a positive fungal culture but where the diagnosis of mucormycosis is documented by an infectious diseases consult and other tools (e.g, radiology reports, histopathology, etc.) will be considered on a case-by-case basis. Renewals will be considered for patients who are responding to therapy but who have not experienced clinical resolution of their condition. Note that requests for renewal must be accompanied by supporting clinical information (Infectious disease consultation/ radiology report). 465 Chronic Renal Failure Drugs EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 465, record 301, corpus 2025-01-01; name match only, not an eligibility decision

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 ↗)

Taro-Posaconazole · DIN 02543311 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2024-05-31 Health Canada: Marketed since 2024-03-25 · brand TARO-POSACONAZOLE · ATC J02AC04 POSACONAZOLE · form Tablet (delayed-release) · route Oral · ingredients POSACONAZOLE 100 MG · company Taro pharmaceuticals inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02543311). DIN 02543311: Taro-Posaconazole Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 081204038; group id 15; item number 0019; lccId None; manufacturer id TAR Source form: DR Tab; strength: 100mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $42.6030; ministry $42.6030 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02543311 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103180

Interchangeable products

GLN-Posaconazole · DIN 02542021 · $42.6030 Mint-Posaconazole · DIN 02544644 · $42.6030 Posanol · DIN 02424622 · $42.6030 Sandoz Posaconazole · DIN 02496259 · $42.6030

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=02543311

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