Active substance
Idarubicin
- SFDA 6
- US FDA 10
- Health Canada 1
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ZAVEDOS 1MG/ML VIAL | 1 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 366.80 | NCE · Prescription | Pfizer Australia Pty LTD | Valid |
| ZAVEDOS 1MG/ML VIAL | 1 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 183.40 | Generic · Prescription | Pfizer Australia Pty LTD | Valid |
| ZAVEDOS 10MG VIAL | 10 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 558.40 | NCE · Prescription | PFIZER ITALY S.R.I | Withdrawn by MAH · Not Marketed |
| ZAVEDOS 10MG VIAL | 10 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 558.40 | NCE · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
| ZAVEDOS 5MG VIAL | 5 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 328.45 | NCE · Prescription | PFIZER ITALY S.R.I | Withdrawn by MAH · Not Marketed |
| ZAVEDOS 5MG VIAL | 5 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 328.45 | NCE · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); ADULT ACUTE MYELOID LEUKAEMIA (AML); PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL)
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| IDAMYCIN PFS | 5MG/5ML (1MG/ML) | solution · intravenous | PFIZER | Prescription | 17 Feb 1997 |
| IDARUBICIN HYDROCHLORIDE | 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | PFIZER | Prescription | 17 Feb 1997 |
| IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML); 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | MEITHEAL | Prescription | 1 May 2002 |
| IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML); 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 14 Dec 2006 |
| IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML); 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | HIKMA PHARMS | Prescription | 15 May 2007 |
| IDAMYCIN | 10MG/VIAL; 5MG/VIAL; 20MG/VIAL | powder · intravenous | PFIZER | Discontinued | 27 Sep 1990 |
| IDARUBICIN HYDROCHLORIDE | 20MG/VIAL; 10MG/VIAL; 5MG/VIAL | powder · intravenous | TEVA PARENTERAL | Discontinued | 1 May 2002 |
| IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML); 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | FRESENIUS KABI USA | Discontinued | 4 Aug 2009 |
| IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML); 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | SANDOZ | Discontinued | 29 Mar 2011 |
| IDARUBICIN HYDROCHLORIDE | 5MG/5ML (1MG/ML); 10MG/10ML (1MG/ML); 20MG/20ML (1MG/ML) | solution · intravenous | RISING | Discontinued | 11 Oct 2012 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| IDARUBICIN | 02410028 | 1 MG / ML | SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
Safety signals and safety-related labeling changes
- US FDA 6 Feb 2026 IDAMYCIN PFS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations - US FDA 27 Apr 2022 IDAMYCIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
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.