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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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DALTEPARIN SODIUM

All injection strengths: Limited Use (codes 186, 187, 188, 189)

Other products in the same Health Canada class (B01A, B01AB) — coverage varies; not interchangeable

  • Enoxaparin (Noromby): general benefit
  • Nadroparin (Fraxiparine): limited Use 186, 187, 188, 189
  • Tinzaparin (Innohep): limited Use 186, 187, 188, 189, 323
  • Apixaban (Eliquis): general benefit
  • Dabigatran etexilate (Pradaxa): general benefit, Not a benefit
  • Edoxaban (Lixiana): general benefit

5 more in the class list below

Fragmin · DIN 02352656 · 10000IU/0.4mL · injection, pre-filled syringe

Limited Use — Reason for Use code 186, 187, 188, 189 requiredMarketed · checked 2026-09-02
StatusLimited Use — Reason for Use code 186, 187, 188, 189 required
Write on scriptLU code 186, 187, 188, 189 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Ontario Limited Use criteria — code 186, 187, 188, 189
Reason for Use code 186 For acute treatment of deep venous thrombosis (DVT), for a maximum of three weeks; Coverage limit: LU Authorization Period: 1 year Reason for Use code 187 For DVT in pregnant or lactating females; Coverage limit: LU Authorization Period: 1 year Reason for Use code 188 For DVT in patients whom treatment with warfarin is not tolerated, or contraindicated; Coverage limit: LU Authorization Period: 1 year Reason for Use code 189 For DVT in patients who have failed treatment with warfarin. Coverage limit: LU Authorization Period: 1 year 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 Dalteparin Brand(s): Fragmin DOSAGE FORM/ STRENGTH: Check formulary or e-formulary for funded products For peri-operative bridging for patients who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Standard Approval Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery. For post-operative prophylaxis of DVT for patients who had hip or knee surgery, and cannot use warfarin. Standard Approval Duration: As requested up to a maximum of 30 days starting on the day of surgery. For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer in patients who do not have a history of or risk factors for heparin-induced thrombocytopenia. Standard Approval Duration: Maximum of 30 days For extended treatment of symptomatic acute venous thromboembolism (VTE) in patients with cancer for whom warfarin treatment is not appropriate on a case-by-case basis. Standard Approval Duration: 6 months 28 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 28, record 7, 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 Dalteparin Brand(s): Fragmin DOSAGE FORM/ STRENGTH: Check e-formulary for funded strengths 1. For peri-operative bridging for patients who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Standard Approval Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after the date of hospital discharge 2. For post-operative prophylaxis of DVT for patients who had hip or knee surgery and cannot use warfarin. Standard Approval Duration: As requested up to a maximum of 30 days starting on the day of surgery 3. For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer in patients who do not have a history of or risk factors for heparin-induced thrombocytopenia. Standard Approval Duration: Maximum of 30 days. 4. For extended treatment of symptomatic acute venous thromboembolism (VTE) in patients with cancer, who cannot use warfarin. Standard Approval Duration: As requested up to 6 months 469 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 469, record 308, corpus 2025-01-01; name match only, not an eligibility decision
How long EAP takes
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 ↗)
No interchangeable product listed in the Ontario extract
Fragmin · DIN 02352656 Manufacturer: Pfizer Canada Inc.; listing date 2011-03-15 Health Canada: Marketed since 2011-02-01 · brand FRAGMIN · ATC B01AB04 DALTEPARIN · form Solution · route Intravenous, Subcutaneous · ingredients DALTEPARIN SODIUM 10000 UNIT/0.4ML · company Pfizer canada ulc · schedule Prescription
Check this DIN again · Health Canada product record

Fragmin: Formulary list price $24.2012/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.2012 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=83791 · Verify on the e-Formulary ↗ (DIN 02352656)

Source record
DIN 02352656: Fragmin Raw flags: sec12=Y, sec3=Y Item: 201200064; group id 253; item number 0452; lccId 00045; manufacturer id PFI Source form: Inj Pref Syr; strength: 10000IU/0.4mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $24.2012; ministry $24.2012 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02352656 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=83791
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=02352656
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (20:12 Coagulants and Anti-Coagulants) and how they are covered

Matched class: 20:12 Coagulants and Anti-Coagulants

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: APIXABAN, ENOXAPARIN, RIVAROXABAN Some products covered without a code (check the product listing): DABIGATRAN ETEXILATE, EDOXABAN, WARFARIN 20:12 Coagulants and Anti-Coagulants

ENOXAPARIN

· 37 products · General benefit · strengths: 20mg/0.2mL, 30mg/0.3mL, 40mg/0.4mL, 60mg/0.6mL, 80mg/0.8mL, 120mg/0.8mL, 100mg/mL, 150mg/mL, 300mg/3mL · Inj Sol-0.2mL Pref Syr (Preservative-Free), Inj Sol-0.3mL Pref Syr (Preservative-Free), Inj Sol-0.4mL Pref Syr (Preservative-Free), Inj Sol-0.6mL Pref Syr (Preservative-Free), Inj Sol-0.8mL Pref Syr (Preservative-Free), Inj Sol-1mL Pref Syr (Preservative-Free), Inj Sol-3mL Vial Pk (With Preservative)

NADROPARIN CALCIUM

· 7 products · Limited Use, codes 186, 187, 188, 189 · strengths: 9500IU/mL, 19000IU/mL · Pref Syr-0.3mL Pk, Pref Syr-0.4mL Pk, Pref Syr-0.6mL Pk, Pref Syr-0.8mL Pk, Pref Syr-1.0mL Pk

TINZAPARIN SODIUM

· 11 products · Limited Use, codes 186, 187, 188, 189, 323 · strengths: 2500IU/0.25mL, 8000IU/0.4mL, 12000IU/0.6mL, 16000IU/0.8mL, 3500IU/0.35mL, 4500IU/0.45mL, 10000IU/0.5mL, 14000IU/0.7mL, 18000IU/0.9mL, 10000IU/mL, 20000IU/mL · Inj Pref Syr, Inj-2mL Pk

APIXABAN

· 38 products · General benefit · strengths: 2.5mg, 5mg · Tab

DABIGATRAN ETEXILATE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit (2), General benefit (4) · strengths: 75mg, 110mg, 150mg · Cap

RIVAROXABAN

· 48 products · General benefit · strengths: 2.5mg, 10mg, 15mg, 20mg · Tab

WARFARIN

· 23 products · Listed, not a benefit (8), General benefit (14), Off-Formulary Interchangeable, not an ODB benefit (1) · strengths: 1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 10mg · Tab

FONDAPARINUX SODIUM

· 4 products · Limited Use, codes 378 (2), Off-Formulary Interchangeable, not an ODB benefit (2) · strengths: 2.5mg/0.5mL, 7.5mg/0.6mL · Inj Sol-Pref Syr 0.5mL Pk (Preservative Free), Inj Sol-Pref Syr 0.6mL Pk (Preservative Free)

TICAGRELOR

· 10 products · Off-Formulary Interchangeable, not an ODB benefit (5), Limited Use, codes 441 (5) · strengths: 60mg, 90mg · Tab

EPTIFIBATIDE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.75mg/mL, 2mg/mL · 100mL Vial Pk, 10mL Vial Pk Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 20:12 20:12:04 Direct Factor Xa Inhibitors

EDOXABAN

· 11 products · General benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (3), General benefit (8) · strengths: 15mg, 30mg, 60mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 20:12:04 20:12:16 Hemostatics

TRANEXAMIC ACID

· 5 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 500mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 20:12:16
Full class listing Related classes: 20:04 Antianemia Drugs, 20:16 Hematopoietic Agents, 20:24 Hemorrheologic Agents Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 Indications Fragmin (dalteparin sodium injection) is indicated for: • Thromboprophylaxis in conjunction with surgery • Treatment of acute deep venous thrombosis • Unstable coronary artery disease (UCAD), i.e., unstable angina and non-Q-wave myocardial infarction • Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency • Extended treatment of symptomatic venous thromboembolism (VTE) to prevent recurrence of venous thromboembolism in patients with cancer • Reduction of deep vein thrombosis (DVT) in hospitalized patients with severely restricted mobility during acute illness. Decreased mortality due to thromboembolic events and complications has not been demonstrated. 1.1 Pediatrics Pediatrics (2 weeks – 18 years): Health Canada has not authorized an indication for pediatric use. There is limited safety and efficacy information on the use of dalteparin in pediatric patients (see Monitoring and Laboratory Tests, 7.1.3 Pediatrics, and Use in Pediatrics (2 weeks – 18 years)). 1.2 Geriatrics Geriatrics: Elderly pat… https://pdf.hres.ca/dpd_pm/00083068.PDF PM date: not printed or not captured Source product: FRAGMIN; DIN 02132621; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
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 |
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.
Source; updated September 15, 2026

Dalteparin (Fragmin)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 28

Dalteparin Brand(s): Fragmin DOSAGE FORM/ STRENGTH: Check formulary or e-formulary for funded products
For peri-operative bridging for patients who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Standard Approval Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery.
For post-operative prophylaxis of DVT for patients who had hip or knee surgery, and cannot use warfarin. Standard Approval Duration: As requested up to a maximum of 30 days starting on the day of surgery.
For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer in patients who do not have a history of or risk factors for heparin-induced thrombocytopenia. Standard Approval Duration: Maximum of 30 days
For extended treatment of symptomatic acute venous thromboembolism (VTE) in patients with cancer for whom warfarin treatment is not appropriate on a case-by-case basis. Standard Approval Duration: 6 months
28

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Dalteparin (Fragmin)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 469

Dalteparin Brand(s): Fragmin DOSAGE FORM/ STRENGTH: Check e-formulary for funded strengths
1. For peri-operative bridging for patients who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin.
Standard Approval Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after the date of hospital discharge
2. For post-operative prophylaxis of DVT for patients who had hip or knee surgery and cannot use warfarin.
Standard Approval Duration: As requested up to a maximum of 30 days starting on the day of surgery
3. For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer in patients who do not have a history of or risk factors for heparin-induced thrombocytopenia.
Standard Approval Duration: Maximum of 30 days.
4. For extended treatment of symptomatic acute venous thromboembolism (VTE) in patients with cancer, who cannot use warfarin.
Standard Approval Duration: As requested up to 6 months
469

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.