SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Ezokamine | 50 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 331.50 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| MYCAMINE 50-10ML VIAL | 5 mg/ml | Injection · Intramuscular use | 1 Vial | SAR 382.50 | NCE · Prescription | ASTELLAS PHARMA INC. | Valid |
| Megmento | 100 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 714.00 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Megmento | 50 mg | Powder for solution for infusion · Intravenous use | 1 Vial | SAR 357.00 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
Indications — CHI Daman Drug Formulary
ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; ENDOCARDITIS; ESOPHAGEAL CANDIDIASIS; Invasive Candidiasis and Candidemia; Pyogenic Arthritis
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| MYCAMINE | 50MG | injectable · injection | FUJISAWA HLTHCARE | Prescription | 16 Mar 2005 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | FRESENIUS KABI USA | Prescription | 17 May 2019 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | XELLIA PHARMS APS | Prescription | 2 Jun 2021 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | HIKMA | Prescription | 9 Jul 2021 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | JIANGSU HANSOH PHARM | Prescription | 9 Jul 2021 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | MEITHEAL | Prescription | 28 Sep 2022 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | ZYDUS PHARMS | Prescription | 24 Oct 2022 |
| MICAFUNGIN IN SODIUM CHLORIDE 0.9% | EQ 50MG BASE/50ML (EQ 1MG BASE/ML); EQ 100MG BASE/100ML (EQ 1MG BASE/ML); EQ 150MG BASE/150ML (EQ 1MG BASE/ML) | solution · intravenous | BAXTER HLTHCARE CORP | Prescription | 29 Sep 2023 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | BIOCON PHARMA | Prescription | 29 May 2024 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | QILU PHARM HAINAN | Prescription | 3 Apr 2025 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | HISUN PHARM HANGZHOU | Prescription | 21 Jan 2026 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | YICHANG HUMANWELL | Prescription | 24 Feb 2026 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | ASPIRO | Prescription | 17 Mar 2026 |
| MYCAMINE | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · intravenous | ASTELLAS | Discontinued | 16 Mar 2005 |
| MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | injectable · intravenous | APOTEX | Discontinued | 5 Nov 2020 |
| MICAFUNGIN | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | powder · intravenous | PH HEALTH | Discontinued | 16 Jun 2021 |
| MICAFUNGIN | EQ 50MG BASE/VIAL; EQ 100MG BASE/VIAL | powder · intravenous | TEVA PHARMS USA INC | Discontinued | 30 Jul 2021 |
EMA European Union — centrally authorised medicines
Mycamine Sandoz Pharmaceuticals d.d. · Authorised · authorised 25 Apr 2008 · ATC J02AX05
Therapeutic indication (EMA)
Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.
Canada Canada — marketed products (Health Canada)
WHO WHO Model List of Essential Medicines (2025)
- 6.3. Antifungal medicines · complementary
Systemic or invasive candidosis
Parenteral > General injections > IV: 50 mg in vial (as sodium) powder for injection; 100 mg in vial (as sodium) powder for injection
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.