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

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IRON SUCROSE

All injection strengths: not a benefit

Other products in the same Health Canada class (B03AC) — coverage varies; not interchangeable

  • Iron ferric carboxymaltose (Ferinject): limited Use 735, 736
  • Ferric derisomaltose (Monoferric): limited Use 610

Venofer · DIN 02243716 · 20mg/mL · injection solution-5mL Pk (Preservative-Free)

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
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

Coverage criteria
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 Iron sucrose Brand(s): Venofer, PMS Iron Sucrose DOSAGE FORM/ STRENGTH: 20 mg/mL Injectable For the treatment of iron-deficiency anemia confirmed by bloodwork where the patient has a demonstrated intolerance1 to oral iron therapy2 OR has not responded to adequate therapy with oral iron2. 1Intolerance must be described. 2Provide name of iron salt, dose, duration of therapy, response etc. Duration of Approval: 1 year Renewals will be considered on a case-by-case basis. Duration of Approval: 2 years 22 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 22, record 3, 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 ↗)
1 brand, same coverage
Venofer · DIN 02243716 Manufacturer: Luitpold Pharmaceuticals Inc.; listing date 2021-03-29 Health Canada: Marketed since 2019-06-19 · brand VENOFER · ATC B03AC IRON, PARENTERAL PREPARATIONS · form Solution · route Intravenous · ingredients IRON (IRON SUCROSE) 20 MG/ML · company American regent, inc · schedule Prescription
Check this DIN again · Health Canada product record

Venofer: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

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=67648 · Verify on the e-Formulary ↗ (DIN 02243716)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02243716). DIN 02243716: Venofer Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 200400023; group id 250; item number 0442; lccId None; manufacturer id LUI Source form: Inj Sol-5mL Pk (Preservative-Free); strength: 20mg/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): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02243716 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=67648
Interchangeable products
PMS-Iron Sucrose · DIN 02502917 · $27.5000
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (20:04 Antianemia Drugs) and how they are covered

Matched class: 20:04 Antianemia Drugs

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: FERROUS SULFATE Some products covered without a code (check the product listing): FERROUS FUMARATE, FERROUS GLUCONATE 20:04 Antianemia Drugs

(IRON) FERRIC CARBOXYMALTOSE

· 1 products · Limited Use, codes 735, 736 · strengths: 50mg/mL · Inj Sol

FERRIC DERISOMALTOSE

· 1 products · Limited Use, codes 610 · strengths: 100mg elemental iron/mL · Inj Sol (Preservative-Free)

FERROUS FUMARATE

· 3 products · Listed, not a benefit (1), General benefit (2) · strengths: 300mg, 60mg/mL · Cap, O/L

FERROUS GLUCONATE

· 2 products · Listed, not a benefit (1), General benefit (1) · strengths: 300mg · Tab

FERROUS SULFATE

· 1 products · General benefit · strengths: 75mg/mL · O/L Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 20:04
Full class listing Related classes: 20:12 Coagulants and Anti-Coagulants, 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 VENOFER® (Iron Sucrose Injection) is indicated in the treatment of iron deficiency anemia in the following patients: • non-dialysis-dependent chronic kidney disease (NDD-CKD) patients receiving an erythropoietin • non-dialysis-dependent chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin • hemodialysis dependent chronic kidney disease (HDD-CKD) patients receiving an erythropoietin • peritoneal dialysis dependent chronic kidney disease (PDD-CKD) patients receiving an erythropoietin. 1.1 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Clinical studies with VENOFER have not identified differences in unintended responses between elderly and younger patients. Nevertheless, dose selection for an elderly patient should be cautious, usually starting with lower doses, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. https://pdf.hres.ca/dpd_pm/00069602.PDF PM date: April 5, 2001 Source product: VENOFER; DIN 02243716; 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

Iron sucrose (Venofer, PMS Iron Sucrose)

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: For the treatment of iron-deficiency anemia confirmed by bloodwork where the patient has a demonstrated intolerance1 to oral iron therapy2 OR has not responded to adequate therapy with oral iron2. 1Intolerance must be described.

Ministry criteria corpus 2025-01-01; page 22

Iron sucrose Brand(s): Venofer, PMS Iron Sucrose DOSAGE FORM/ STRENGTH: 20 mg/mL Injectable
For the treatment of iron-deficiency anemia confirmed by bloodwork where the patient has a demonstrated intolerance1 to oral iron therapy2 OR has not responded to adequate therapy with oral iron2. 1Intolerance must be described.
2Provide name of iron salt, dose, duration of therapy, response etc.
Duration of Approval: 1 year
Renewals will be considered on a case-by-case basis.
Duration of Approval: 2 years
22

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