Dexrazoxane | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Dexrazoxane
Europe

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Dexrazoxane

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

15 API Suppliers, 8 USDMF, 1 JDMF, 2 EU WC, 4 NDC API, 7 Listed Suppliers

15 API Suppliers
8 USDMF
1 JDMF
2 EU WC
4 NDC API
7 Listed Suppliers

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 11 FDA Orange Book, 6 Europe, 2 Canada

19 FDF Dossiers
11 FDA Orange Book
6 Europe
2 Canada

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Actylis

1 Actylis

DIGITAL CONTENT

4 News #PharmaBuzz

4 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 Regulatory FDF Prices

2 Regulatory FDF Prices

MARKET PLACE

4 APIs, 2 FDF Dossiers

4 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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filter Applicant Reset all filters

6 All

01 1CLINIGEN HEALTHCARE LTD

02 1Clinigen Healthcare Limited

03 2Cnx Therapeutics Ireland Limited

04 1Cnx Therapeutics Ireland Ltd

05 1Novartis Sweden Ab

filter Active Ingredients Reset all filters

6 All

01 4Dexrazoxane

02 2Dexrazoxane Hydrochloride

filter Dosage Form Reset all filters

6 All

01 1Dexrazoxano 500Mg 1 Unit Parenteral Use

02 1Powder For Concentrate And Solvent For Infusion Solution

03 1Powder For Infusion Solution

04 1Powder to concentrate and liquid to the infusion fluid, resolution

05 2Solution For Injection

filter Country Reset all filters

6 All

01 1Italy

02 1Norway

03 2Spain

04 2Sweden

filter Brand Name Reset all filters

6 All

01 3Cardioxane

02 3Savene

List of Suppliers

Product Main Page

01

CLINIGEN HEALTHCARE LTD

Fall Technical Meeting

Not Confirmed

CLINIGEN HEALTHCARE LTD

Fall Technical Meeting

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Italy

Dexrazoxane

Brand Name : Cardioxane

Dosage Form : Dexrazoxano 500Mg 1 Unit Parenteral Use

Dosage Strength : 1 ampoule EV 500 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Clinigen Healthcare Limited

Fall Technical Meeting

Not Confirmed

Clinigen Healthcare Limited

Fall Technical Meeting

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Norway

Dexrazoxane

Brand Name : Savene

Dosage Form : Powder to concentrate and liquid to the infusion fluid, resolution

Dosage Strength : 20 mg/ml

Packaging : Set

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Cnx Therapeutics Ireland Ltd

Fall Technical Meeting

Not Confirmed

Cnx Therapeutics Ireland Ltd

Fall Technical Meeting

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dexrazoxane Hydrochloride

Brand Name : Savene

Dosage Form : Solution For Injection

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 28/07/2006

Application Number : 20050924000017

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Cnx Therapeutics Ireland Limited

Fall Technical Meeting

Not Confirmed

Cnx Therapeutics Ireland Limited

Fall Technical Meeting

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dexrazoxane

Brand Name : Cardioxane

Dosage Form : Powder For Infusion Solution

Dosage Strength : 500MG

Packaging :

Approval Date : 2006-03-31

Application Number : 67673

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Cnx Therapeutics Ireland Limited

Fall Technical Meeting

Not Confirmed

Cnx Therapeutics Ireland Limited

Fall Technical Meeting

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dexrazoxane

Brand Name : Savene

Dosage Form : Powder For Concentrate And Solvent For Infusion Solution

Dosage Strength : 20MG

Packaging :

Approval Date : 2007-02-21

Application Number : 06350001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Novartis Sweden Ab

Fall Technical Meeting

Not Confirmed

Novartis Sweden Ab

Fall Technical Meeting

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dexrazoxane Hydrochloride

Brand Name : Cardioxane

Dosage Form : Solution For Injection

Dosage Strength : 500mg

Packaging :

Approval Date : 05/07/2006

Application Number : 20051011000019

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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