Active substance
Protamine
- SFDA 2
- US FDA 7
- Health Canada 2
- WHO EML 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| PROSULF 10MG/ML SOLUTION FOR INJECTION | 1 % | Solution for injection · Intravenous use | 10 Ampoule | SAR 278.05 | Biological · Prescription | WOCKHARDT UK LIMITED | Valid |
| PROSULF SULPHATE INJ 1% | 1 % | Solution for injection · Intravenous use | 5 Ampoule | SAR 3.20 | Biological · Prescription | WOCKHARDT UK LIMITED | Invalid · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA-SUPPORTIVE AGENTS/ ANTICOAGULATION FOR PATIENTS UNDERGOING CARDIOPULMONARY BYPASS (CBP) & REVERSAL; VENOUS THROMBOEMBOLISM DISEASE (VTE)-LIFE-THREATENING BLEEDING DUE TO ANTICOAGULANTS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROTAMINE SULFATE | 50MG/5ML (10MG/ML); 250MG/25ML (10MG/ML) | solution · intravenous | FRESENIUS KABI USA | Prescription | 7 Apr 1987 |
| PROTAMINE SULFATE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 250MG/25ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · intravenous | LILLY | Discontinued | 13 Aug 1969 |
| PROTAMINE SULFATE | 50MG/5ML (10MG/ML) | solution · intravenous | HIKMA PHARMS | Discontinued | 5 Nov 1986 |
| PROTAMINE SULFATE | 250MG/25ML (10MG/ML); 50MG/5ML (10MG/ML) | solution · intravenous | HIKMA PHARMS | Discontinued | 5 Nov 1986 |
| PROTAMINE SULFATE | 10MG/ML | injectable · injection | QUAD PHARMS | Discontinued | |
| PROTAMINE SULFATE | 50MG/VIAL | injectable · injection | QUAD PHARMS | Discontinued | |
| PROTAMINE SULFATE | 50MG/VIAL; 250MG/VIAL | powder · intravenous | PHARMACIA AND UPJOHN | Discontinued |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| PROTAMINE SULFATE INJECTION USP | 02231674 | 10 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| PROTAMINE SULFATE INJECTION, USP | 02139537 | 10 MG / ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
WHO WHO Model List of Essential Medicines (2025)
- 10.2. Medicines affecting coagulation · core (EML); complementary (EMLc)
Haemorrhagic disorder due to circulating anticoagulants or coagulation factors inhibitors
Parenteral > General injections > IV: 10 mg per mL in 5 mL ampoule or vial
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.