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Chemistry

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FDF Dossiers

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01

Abacus Medicine

Denmark
Antibody Engineering
Not Confirmed
arrow

Abacus Medicine

Denmark
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21/12/2021

Application Number : 20210616000019

Regulatory Info : Approved

Registration Country : Sweden

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02

Abacus Medicine

Denmark
Antibody Engineering
Not Confirmed
arrow

Abacus Medicine

Denmark
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21/12/2021

Application Number : 20210603000039

Regulatory Info : Approved

Registration Country : Sweden

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03

Ebb Medical

Sweden
Antibody Engineering
Not Confirmed
arrow

Ebb Medical

Sweden
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/07/2024

Application Number : 20240416000186

Regulatory Info : Approved

Registration Country : Sweden

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04

F. Hoffmann-La Roche

Switzerland
Antibody Engineering
Not Confirmed
arrow

F. Hoffmann-La Roche

Switzerland
arrow
Antibody Engineering
Not Confirmed

Dornase alfa

Brand Name : Pulmozyme

Dosage Form : Inhalation liquid for nebulizer, solution

Dosage Strength : 1mg/ml

Packaging : Ampoule av plast 30 2.5ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

Genentech

U.S.A
Antibody Engineering
Not Confirmed
arrow

Genentech

U.S.A
arrow
Antibody Engineering
Not Confirmed

DORNASE ALFA

Brand Name : PULMOZYME

Dosage Form : VIAL

Dosage Strength : 1MG/ML

Packaging :

Approval Date :

Application Number : 103532

Regulatory Info :

Registration Country : USA

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06

Medartuum

Sweden
Antibody Engineering
Not Confirmed
arrow

Medartuum

Sweden
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 20/11/2013

Application Number : 20130228000026

Regulatory Info : Approved

Registration Country : Sweden

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07

Medartuum

Sweden
Antibody Engineering
Not Confirmed
arrow

Medartuum

Sweden
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 26/09/2018

Application Number : 20170530000062

Regulatory Info : Approved

Registration Country : Sweden

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08

Medartuum

Sweden
Antibody Engineering
Not Confirmed
arrow

Medartuum

Sweden
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 24/10/2018

Application Number : 20180321000065

Regulatory Info : Approved

Registration Country : Sweden

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09

Medartuum

Sweden
Antibody Engineering
Not Confirmed
arrow

Medartuum

Sweden
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21/11/2018

Application Number : 20180110000023

Regulatory Info : Approved

Registration Country : Sweden

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10

Antibody Engineering
Not Confirmed
arrow
arrow
Antibody Engineering
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 10/08/2021

Application Number : 20210115000046

Regulatory Info : Approved

Registration Country : Sweden

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