Active substance
Argatroban
- SFDA 2
- US FDA 16
- Health Canada 2
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ARIGAL 250MG/2.5ML | 100 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 2686.00 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| ARIGAL 50MG/50ML | 1 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 537.20 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
Indications — CHI Daman Drug Formulary
NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); VENOUS THROMBOEMBOLISM DISEASE (VTE)-PROPHYLAXIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ARGATROBAN IN SODIUM CHLORIDE | 125MG/125ML (1MG/ML) | injectable · intravenous | PLANO PHARMS | Prescription | 9 May 2011 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML); 50MG/50ML (1MG/ML) | injectable · injection | HIKMA PHARM CO LTD | Prescription | 5 Jan 2012 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML) | injectable · injection | PH HEALTH | Prescription | 30 Jun 2014 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML) | injectable · injection | MYLAN INSTITUTIONAL | Prescription | 30 Jun 2014 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML) | injectable · injection | HOSPIRA | Prescription | 21 Sep 2016 |
| ARGATROBAN IN SODIUM CHLORIDE | 125MG/125ML (1MG/ML) | injectable · intravenous | GLAND | Prescription | 22 May 2017 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML) | injectable · injection | AMNEAL PHARMS CO | Prescription | 26 Jan 2018 |
| ARGATROBAN IN SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | solution · intravenous | EUGIA PHARMA SPECLTS | Prescription | 27 Nov 2018 |
| ARGATROBAN | 50MG/50ML (1MG/ML) | injectable · injection | CAPLIN | Prescription | 21 Jan 2021 |
| ARGATROBAN IN SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | solution · intravenous | ACCORD HLTHCARE | Prescription | 7 Jun 2021 |
| ARGATROBAN | 50MG/50ML (1MG/ML) | injectable · injection | GLAND | Prescription | 31 Jul 2023 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML) | injectable · injection | SANDOZ | Discontinued | 30 Jun 2000 |
| ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | solution · intravenous | SANDOZ | Discontinued | 9 May 2011 |
| ARGATROBAN IN SODIUM CHLORIDE | 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · intravenous | CIPLA | Discontinued | 29 Jun 2011 |
| ARGATROBAN IN 0.9% SODIUM CHLORIDE | 250MG/250ML (1MG/ML) | injectable · intravenous | TEVA PHARMS USA | Discontinued | 15 Dec 2014 |
| ARGATROBAN | 250MG/2.5ML (100MG/ML) | injectable · injection | FRESENIUS KABI USA | Discontinued | 23 Mar 2015 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ARGATROBAN | 02548968 | 1 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| ARGATROBAN FOR INJECTION | 02561557 | 100 MG / ML | SOLUTION · INTRAVENOUS | JUNO PHARMA CANADA INC. |
Safety signals and safety-related labeling changes
- US FDA 25 Sep 2026 ARGATROBAN IN SODIUM CHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - US FDA 31 Jul 2026 ARGATROBAN IN SODIUM CHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - US FDA 13 Jul 2026 ARGATROBAN — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - US FDA 16 Jun 2026 ARGATROBAN — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - US FDA 10 Jun 2026 ARGATROBAN IN SODIUM CHLORIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 10 Jun 2026 ARGATROBAN IN SODIUM CHLORIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 3 Jun 2026 ARGATROBAN IN DEXTROSE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - US FDA 15 May 2026 ARGATROBAN — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
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.