Savene CNX Therapeutics Ireland Limited · Authorised · authorised 27 Jul 2006 · ATC V03AF02
Therapeutic indication (EMA)
Savene is indicated for the treatment of anthracycline extravasation.
Active substance
Dexrazoxane
- US FDA 6
- EMA 1
- Health Canada 3
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DEXRAZOXANE HYDROCHLORIDE | EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 28 Sep 2004 |
| DEXRAZOXANE HYDROCHLORIDE | EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL | injectable · injection | EUGIA PHARMA | Prescription | 19 Oct 2011 |
| DEXRAZOXANE HYDROCHLORIDE | EQ 500MG BASE/VIAL; EQ 250MG BASE/VIAL | injectable · injection | GLAND | Prescription | 28 Nov 2016 |
| DEXRAZOXANE HYDROCHLORIDE | EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL | injectable · injection | MSN | Prescription | 26 Mar 2025 |
| ZINECARD | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | PFIZER | Discontinued | 26 May 1995 |
| TOTECT | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | CLINIGEN | Discontinued | 6 Sep 2007 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DEXRAZOXANE FOR INJECTION | 02544083 | 250 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | JUNO PHARMA CANADA INC. |
| DEXRAZOXANE FOR INJECTION | 02557649 | 250 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | HIKMA CANADA LIMITED |
| ZINECARD | 02153432 | 250 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | PFIZER CANADA ULC |
Safety signals and safety-related labeling changes
- US FDA 12 May 2025 ZINECARD — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Nov 2020 TOTECT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - MHRA 11 Dec 2014 Dexrazoxane (Cardioxane): restriction of use
Use restricted to adults with advanced or metastatic breast cancer only.
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.