Active substance
Mitoxantrone
- SFDA 4
- US FDA 9
- Health Canada 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MITOXANTRON EBEWE 2MG-1ML SOL. FOR INFU | 2 mg/ml | Solution · Intravenous use | 1 Vial | SAR 396.70 | Generic · Prescription | EBEWE PHARMA | Valid |
| NOVANTRONE VIAL 2MG-ML | 2 mg/ml | Injection · Intravenous use | 1 Vial | SAR 978.65 | NCE · Prescription | LEDERLE | Withdrawn by MAH · Not Marketed |
| NOVANTRONE VIAL 2MG-ML | 2 mg/ml | Injection · Intravenous use | 1 Vial | SAR 650.00 | NCE · Prescription | LEDERLE | Withdrawn by MAH · Not Marketed |
| NOVANTRONE VIAL 2MG-ML | 2 mg/ml | Injection · Intravenous use | 1 Vial | SAR 810.65 | NCE · Prescription | LEDERLE | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); ADULT ACUTE MYELOID LEUKAEMIA (AML); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; MULTIPLE SCLEROSIS; PROSTATE CANCER
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML); EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML); EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | injectable · injection | HIKMA | Prescription | 11 Apr 2006 |
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML); EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML); EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | injectable · injection | HOSPIRA | Prescription | 11 Apr 2006 |
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML); EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML); EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | injectable · injection | MEITHEAL | Prescription | 11 Apr 2006 |
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML); EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML); EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | injectable · injection | FRESENIUS KABI USA | Prescription | 11 Apr 2006 |
| NOVANTRONE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | EMD SERONO | Discontinued | 23 Dec 1987 |
| NOVANTRONE | EQ 2MG BASE/ML | injectable · injection | SERONO INC | Discontinued | 13 Oct 2000 |
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML); EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML); EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | injectable · injection | FRESENIUS KABI ONCOL | Discontinued | 14 May 2008 |
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML); EQ 30MG BASE/15ML (EQ 2MG BASE/ML) | injectable · injection | RISING | Discontinued | 13 Apr 2009 |
| MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | injectable · injection | RISING | Discontinued | 11 Dec 2012 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MITOXANTRONE INJECTION | 02286300 | 2 MG / ML | SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
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.