Overview
Micafungin is an antifungal drug. It belongs to the antifungal class of compounds known as echinocandins and exerts its effect by inhibiting the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall.
Indication
Indicated for the treatment of candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, as well as esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation. Micafungin is also used as an alternative for the treatment of oropharyngeal candidiases and has been used with some success as primary or salvage therapy, alone or in combination with other antifungals, for the treatment of invasive aspergillosis. Indicated for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
Associated Conditions
- Abscesses
- Aspergillosis
- Candidemia
- Candidiasis
- Esophageal Candidiasis
- Fungal Infections
- Fungal peritonitis caused by Candida
- Acute disseminated Candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/14 | Phase 4 | Completed | |||
2023/03/27 | Phase 4 | Recruiting | |||
2022/08/11 | Phase 4 | Completed | |||
2021/02/04 | Phase 4 | UNKNOWN | |||
2021/01/28 | Phase 4 | Not yet recruiting | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | ||
2019/04/08 | Phase 4 | Terminated | Fadoi Foundation, Italy | ||
2018/02/05 | Phase 2 | Completed | |||
2017/06/02 | N/A | Completed | |||
2017/04/06 | Phase 4 | Completed | |||
2016/02/10 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Apotex Corp. | 60505-6119 | INTRAVENOUS | 10 mg in 1 mL | 7/12/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1725 | INTRAVENOUS | 20 mg in 1 mL | 6/24/2023 | |
| Fresenius Kabi USA, LLC | 63323-729 | INTRAVENOUS | 100 mg in 1 1 | 9/30/2020 | |
| Zydus Lifesciences Limited | 70771-1683 | INTRAVENOUS | 10 mg in 1 mL | 11/23/2022 | |
| Civica, Inc. | 72572-427 | INTRAVENOUS | 100 mg in 1 1 | 9/28/2022 | |
| Zydus Lifesciences Limited | 70771-1684 | INTRAVENOUS | 20 mg in 1 mL | 11/23/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9361 | INTRAVENOUS | 10 mg in 1 mL | 7/26/2021 | |
| Astellas Pharma US, Inc. | 0469-3211 | INTRAVENOUS | 20 mg in 1 mL | 7/23/2020 | |
| Apotex Corp. | 60505-6120 | INTRAVENOUS | 20 mg in 1 mL | 7/12/2023 | |
| Sagent Pharmaceuticals | 25021-191 | INTRAVENOUS | 100 mg in 5 mL | 3/4/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/25/2008 | ||
Authorised | 4/25/2008 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MYCAMINE POWDER FOR SOLUTION FOR INFUSION 50MG/VIAL | SIN14464P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 50 mg/vial | 12/18/2013 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MYCAMINE micafungin (as sodium) 50 mg powder for injection vial | 196108 | Medicine | A | 5/8/2013 | |
| MYCAMINE micafungin (as sodium) 100 mg powder for injection vial | 196109 | Medicine | A | 5/8/2013 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MICAFUNGIN SODIUM FOR INJECTION | hikma canada limited | 02532360 | Powder For Solution - Intravenous | 100 MG / VIAL | 5/29/2023 |
| MYCAMINE | 02294222 | Powder For Solution - Intravenous | 50 MG / VIAL | 9/18/2007 | |
| MYCAMINE | 02311054 | Powder For Solution - Intravenous | 100 MG / VIAL | 12/17/2009 | |
| MICAFUNGIN SODIUM FOR INJECTION | hikma canada limited | 02532344 | Powder For Solution - Intravenous | 50 MG / VIAL | 5/29/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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