Active substance
Dalteparin
- US FDA 3
- Health Canada 10
- NHS prices 10
- WHO EML 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FRAGMIN | 2,500IU/0.2ML (12,500IU/ML); 5,000IU/0.2ML (25,000IU/ML); 10,000IU/ML (10,000IU/ML); 7,500IU/0.3ML (25,000IU/ML); 95,000IU/3.8ML (25,000IU/ML); 12,500IU/0.5ML (25,000IU/ML); 15,000IU/0.6ML (25,000IU/ML); 18,000IU/0.72ML (25,000IU/ML); 10,000IU/4ML (2,500IU/ML) | injectable · subcutaneous | PFIZER | Prescription | 22 Dec 1994 |
| FRAGMIN | 10,000IU/0.4ML (25,000IU/ML); 95,000IU/9.5ML (10,000IU/ML) | injectable · subcutaneous | PFIZER | Discontinued | 22 Dec 1994 |
| FRAGMIN | 7,500 IU/0.75ML | injectable · injection | PFIZER | Discontinued | 22 Dec 1994 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FRAGMIN | 02132621 | 2500 UNIT / 0.2 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
| FRAGMIN | 02132648 | 5000 UNIT / 0.2 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
| FRAGMIN | 02231171 | 25000 UNIT / ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS | PFIZER CANADA ULC |
| FRAGMIN | 02352648 | 7500 UNIT / 0.3 ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS | PFIZER CANADA ULC |
| FRAGMIN | 02352656 | 10000 UNIT / 0.4 ML | SOLUTION · INTRAVENOUS; SUBCUTANEOUS | PFIZER CANADA ULC |
| FRAGMIN | 02352664 | 12500 UNIT / 0.5 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
| FRAGMIN | 02352672 | 15000 UNIT / 0.6 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
| FRAGMIN | 02352680 | 18000 UNIT / 0.72 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
| FRAGMIN | 02430789 | 3500 UNIT / 0.28 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
| FRAGMIN | 02494582 | 16500 UNIT / 0.66 ML | SOLUTION · SUBCUTANEOUS; INTRAVENOUS | PFIZER CANADA ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Dalteparin sodium 10,000units/0.4ml solution for injection pre-filled syringes | £33.49 | 5 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 10,000units/1ml solution for injection pre-filled syringes | £33.49 | 5 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 10,000units/4ml solution for injection ampoules | £51.22 | 10 ampoule | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 100,000units/4ml solution for injection vials | £48.66 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 12,500units/0.5ml solution for injection pre-filled syringes | £36.70 | 5 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 15,000units/0.6ml solution for injection pre-filled syringes | £43.31 | 5 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 18,000units/0.72ml solution for injection pre-filled syringes | £50.82 | 5 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 2,500units/0.2ml solution for injection pre-filled syringes | £23.67 | 10 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 5,000units/0.2ml solution for injection pre-filled syringes | £36.03 | 10 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Dalteparin sodium 7,500units/0.3ml solution for injection pre-filled syringes | £45.00 | 10 pre-filled disposable injection | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 10.2. Medicines affecting coagulation · core
Therapeutic equivalent to enoxaparin for Acute ischaemic heart disease; Therapeutic equivalent to enoxaparin for Venous thromboembolism
Safety signals and safety-related labeling changes
- US FDA 24 Oct 2024 FRAGMIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.