Active substance
Amphotericin b
- SFDA 4
- US FDA 16
- Health Canada 2
- NHS prices 1
- WHO EML 2
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ABELCET 5MG/ML IV VIAL | 100 mg | Intravenous infusion · Intravenous use | 1 Vial | SAR 720.75 | NCE · Prescription | Acino France SAS | Valid |
| AMBISOME 50 MG VIAL | 50 mg | Powder for concentrate for dispersion for infusion · Intravenous use | 10 Vial | SAR 3484.40 | NCE · Prescription | GILEAD SCIENCES LIMITED (CORK) | Valid |
| TRASPOR | 50 mg | Powder for concentrate for dispersion for infusion · Intravenous use | 1 Vial | SAR 325.20 | Generic · Prescription | ALPHA PHARMA INDUSTRY | Valid |
| AMBISOME 50MG VIAL | 50 mg | Powder for solution for infusion · Intravenous use | 10 Vial | SAR 6750.00 | NCE · Prescription | GILEAD SCIENCES LIMITED | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; ENDOCARDITIS; ESOPHAGEAL CANDIDIASIS; FUNGAL GIT - ASPERGILLOSIS; FUNGAL GIT - BLASTOMYCOSIS; FUNGAL GIT - COCCIDIOIDOMYCOSIS; FUNGAL GIT - HISTOPLASMOSIS; FUNGAL GIT - MUCORMYCOSIS; Invasive Candidiasis and Candidemia; Pyogenic Arthritis
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AMPHOTERICIN B | 50MG/VIAL | injectable · injection | XGEN PHARMS | Prescription | 29 Apr 1992 |
| AMBISOME | 50MG/VIAL | injectable, liposomal · injection | ASTELLAS | Prescription | 11 Aug 1997 |
| AMPHOTERICIN B | 50MG/VIAL | injectable, liposomal · injection | SPIL | Prescription | 14 Dec 2021 |
| AMPHOTERICIN B | 50MG/VIAL | injectable, liposomal · injection | EUGIA PHARMA | Prescription | 17 Nov 2022 |
| AMPHOTERICIN B | 50MG/VIAL | injectable, liposomal · injection | AVET LIFESCIENCES | Prescription | 2 Jun 2025 |
| AMPHOTERICIN B | 50MG/VIAL | injectable, liposomal · injection | MYLAN LABS LTD | Prescription | 30 Jun 2025 |
| FUNGIZONE | 3% | lotion · topical | APOTHECON | Discontinued | 12 Nov 1964 |
| FUNGIZONE | 3% | ointment · topical | APOTHECON | Discontinued | 13 Oct 1965 |
| FUNGIZONE | 3% | cream · topical | APOTHECON | Discontinued | 7 Feb 1966 |
| FUNGIZONE | 50MG/VIAL | injectable · injection | APOTHECON | Discontinued | 1 Mar 1966 |
| FUNGIZONE | 100MG/ML | suspension · oral | BRISTOL MYERS SQUIBB | Discontinued | 2 Jun 1971 |
| AMPHOTERICIN B | 50MG/VIAL | injectable · injection | ABRAXIS PHARM | Discontinued | 13 Apr 1987 |
| AMPHOTERICIN B | 50MG/VIAL | injectable · injection | TEVA PARENTERAL | Discontinued | 31 Mar 1995 |
| ABELCET | 5MG/ML | injectable, lipid complex · injection | LEADIANT BIOSCI INC | Discontinued | 20 Nov 1995 |
| AMPHOTEC | 50MG/VIAL; 100MG/VIAL | injectable, lipid complex · injection | ALKOPHARMA USA | Discontinued | 22 Nov 1996 |
| AMPHOTERICIN B | 50MG/VIAL | injectable · injection | ABBOTT | Discontinued | 23 Dec 1996 |
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Amphotericin B 50mg powder for solution for infusion vials | £16.21 | 1 vial | 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)
- 6.3. Antifungal medicines · core
Candidosis; Blastomycosis; Cryptococcosis; Coccidioidomycosis; Aspergillosis; Sporotrichosis; Histoplasmosis
Parenteral > General injections > IV: 50 mg in vial powder for injection (liposomal complex); 50 mg in vial powder for injection (as sodium deoxycholate) - 6.5.2. Antileishmaniasis medicines · core
Visceral leishmaniasis
Parenteral > General injections > IV: 50 mg in vial powder for injection (liposomal complex); 50 mg in vial powder for injection (as sodium deoxycholate)
Safety signals and safety-related labeling changes
- EMA PRAC 11 Jan 2024 PRAC signal: Hyperkalaemia
Action for MAH: update of the product information: Yes - EMA PRAC 31 Aug 2023 PRAC signal: Hyperkalaemia
Action for MAH: update of the product information: No
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.