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CEP/COS Certifications

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Chemistry

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FDA Orange Book

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BIO Partnering at JPM
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DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 150MG/ML

Approval Date :

Application Number : 761055

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 200mg

Packaging :

Approval Date : 06/05/2019

Application Number : 20180307000072

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 200mg

Packaging :

Approval Date : 06/05/2019

Application Number : 20180307000065

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 300mg

Packaging :

Approval Date : 17/10/2019

Application Number : 20191129000010

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 300mg

Packaging :

Approval Date : 26/09/2017

Application Number : 20161109000064

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 100mg

Packaging :

Approval Date : 04/04/2022

Application Number : 20210308000020

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dupilumab

Brand Name : Dupixent

Dosage Form : Injectable Solution In Pre-Filled Pen

Dosage Strength : 300MG

Packaging :

Approval Date : 2019-12-10

Application Number : 1171229018

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dupilumab

Brand Name : Dupixent

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 300MG

Packaging :

Approval Date : 2017-10-20

Application Number : 1171229006

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dupilumab

Brand Name : Dupixent

Dosage Form : Injectable Solution In Pre-Filled Pen

Dosage Strength : 200MG

Packaging :

Approval Date : 2019-12-10

Application Number : 1171229014

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Dupilumab

Brand Name : Dupixent

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 200MG

Packaging :

Approval Date : 2019-12-10

Application Number : 1171229010

Regulatory Info : Authorized

Registration Country : Spain

Sanofi Company Banner
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Canada

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Schedule D

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 300MG/2ML

Packaging : 2ML

Approval Date :

Application Number : 2470365

Regulatory Info : Schedule D

Registration Country : Canada

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Prescription

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 200MG/1.14ML

Packaging :

Approval Date :

Application Number : 2492504

Regulatory Info : Prescription

Registration Country : Canada

Sanofi Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Schedule D

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 300MG/2ML

Packaging :

Approval Date :

Application Number : 2510049

Regulatory Info : Schedule D

Registration Country : Canada

Sanofi Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Schedule D

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 200MG/1.14ML

Packaging :

Approval Date :

Application Number : 2524252

Regulatory Info : Schedule D

Registration Country : Canada

Sanofi Company Banner
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