Active substance
Epirubicin
- SFDA 14
- US FDA 15
- Health Canada 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Epirubicin “Ebewe” 10mg/5ml | 2 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 54.20 | Generic · Prescription | EBEWE PHARMA | Valid |
| Epirubicin “Ebewe” 200mg/100ml | 2 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 509.90 | Generic · Prescription | EBEWE PHARMA | Valid |
| Epirubicin “Ebewe” 50mg/25ml | 2 mg/ml | Concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 240.25 | Generic · Prescription | EBEWE PHARMA | Valid |
| FARMARUBICIN 10MG/5ML INJECTION | 2 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 86.80 | Generic · Prescription | Pfizer Australia Pty LTD | Valid |
| FARMARUBICIN 50MG/25ML VIAL | 2 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 166.05 | Generic · Prescription | Pfizer Australia Pty LTD | Valid |
| EPIRUBICIN HCL | 2 mg/ml | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 39.45 | Generic · Prescription | Accord Healthcare Limited | Withdrawn by MAH · Not Marketed |
| EPIRUBICIN JAZEERA 2MG/ML SOLUTION FOR INJECTION | 2 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 478.05 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| EPIRUBICIN JAZEERA 2MG/ML SOLUTION FOR INJECTION | 2 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 180.20 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| EPIRUBICIN JAZEERA 2MG/ML SOLUTION FOR INJECTION | 2 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 40.65 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| Epirubicin Hydrochloride 2mg/ml Solution for Injection or Infusion | 2 mg/ml | Concentrate for solution for infusion · Intravenous, Intravesical | 1 Vial | SAR 148.95 | Generic · Prescription | Accord Healthcare Limited | Withdrawn by MAH · Not Marketed |
| FARMARUBICIN 10MG VIAL | 10 mg | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 52.20 | NCE · Prescription | PFIZER ITALY S.R.I | Withdrawn by MAH · Not Marketed |
| FARMARUBICIN 10MG VIAL | 10 mg | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 52.20 | NCE · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
| FARMORUBICIN 50MG VIAL | 50 mg | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 189.50 | NCE · Prescription | PFIZER ITALY S.R.I | Withdrawn by MAH · Not Marketed |
| FARMORUBICIN 50MG VIAL | 50 mg | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 222.40 | NCE · Prescription | PFIZER | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
BREAST CANCER EARLY HER-2 -VE; BREAST CANCER MET.HER-2 -VE; ESOPHAGEAL CANCER; GASTRIC CANCER; SOFT TISSUE SARCOMA - LEIOMYOSARCOMA & LIPOSARCOMA; T-CELL LYMPHOMA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ELLENCE | 200MG/100ML (2MG/ML); 50MG/25ML (2MG/ML) | injectable · injection | PFIZER INC | Prescription | 15 Sep 1999 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | HIKMA PHARMS | Prescription | 27 Jun 2007 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | IMPAX LABS INC | Prescription | 9 Aug 2007 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | CIPLA LTD | Prescription | 22 Oct 2007 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | injectable · injection | EPIC PHARMA LLC | Prescription | 24 Jun 2009 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/VIAL; 200MG/VIAL | powder · intravenous | HOSPIRA | Discontinued | 15 Sep 2006 |
| EPIRUBICIN HYDROCHLORIDE | 10MG/5ML (2MG/ML); 50MG/25ML (2MG/ML); 150MG/75ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | HOSPIRA | Discontinued | 19 Apr 2007 |
| EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/ML); 50MG/25ML (2MG/ML) | injectable · injection | FRESENIUS KABI USA | Discontinued | 20 Aug 2007 |
| EPIRUBICIN HYDROCHLORIDE | 10MG/5ML (2MG/ML); 50MG/25ML (2MG/ML); 150MG/75ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | FRESENIUS KABI USA | Discontinued | 15 Oct 2007 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | PHARMOBEDIENT | Discontinued | 28 Nov 2007 |
| EPIRUBICIN HYDROCHLORIDE | 10MG/5ML (2MG/ML); 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | ACTAVIS TOTOWA | Discontinued | 18 Sep 2008 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | EBEWE PHARMA | Discontinued | 22 Dec 2009 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | HISUN PHARM HANGZHOU | Discontinued | 25 Mar 2010 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | PHARMOBEDIENT | Discontinued | 15 Apr 2011 |
| EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML); 200MG/100ML (2MG/ML) | injectable · injection | PHARMOBEDIENT | Discontinued | 12 Mar 2012 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| EPIRUBICIN HYDROCHLORIDE INJECTION | 02324091 | 2 MG / ML | SOLUTION · INTRAVENOUS | TEVA CANADA LIMITED |
Safety signals and safety-related labeling changes
- US FDA 26 Jul 2019 ELLENCE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.