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01 1Abacus Medicine A/S

02 1Cherubino Limited

03 1EJ Busuttil Ltd

04 1F. Hoffmann-La Roche, Ltd.

05 1Medartuum Ab

06 1Roche Eesti Osaühing

07 1Roche Farma Sa

08 1Roche Norge AS

09 1Roche Pharma (Switzerland) Ag

10 1Roche Pharmaceuticals A/S

11 1Roche Products Limited

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
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Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution For Inhalation

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 12-12-2017

Application Number : 28106018917

Regulatory Info : Prescription

Registration Country : Denmark

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution For Inhalation

Dosage Strength : 2.5mg/2.5ml

Packaging :

Approval Date : 28/04/1994

Application Number : 52623

Regulatory Info : Allowed

Registration Country : Switzerland

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

dornase alpha

Brand Name : Pulmozyme®

Dosage Form : Solution For Inhalation

Dosage Strength : 2500IU/2.5ml

Packaging :

Approval Date : 10-09-2020

Application Number :

Regulatory Info :

Registration Country : Moldova

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dornase alfa

Brand Name : Pulmozyme

Dosage Form : Solution For Inhalation

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dornase alfa

Brand Name : Pulmozyme

Dosage Form : Nebuliser Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dornasa Alfa

Brand Name : Pulmozyme

Dosage Form : Solution For Nebulizer Inhalation

Dosage Strength : 2500UNIT

Packaging :

Approval Date : 01-05-1994

Application Number : 60326

Regulatory Info : Authorized

Registration Country : Spain

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution For Inhalation

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 23-02-1994

Application Number : 28101546293

Regulatory Info : Prescription

Registration Country : Denmark

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution For Inhalation

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 28-08-2023

Application Number : 28106969023

Regulatory Info : Prescription

Registration Country : Denmark

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09

Cherubino Limited

Country
ASPEN
Not Confirmed
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Cherubino Limited

Country
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ASPEN
Not Confirmed

Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution for Nebuliser

Dosage Strength : 2.5MG

Packaging :

Approval Date : 2019-07-19

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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10

EJ Busuttil Ltd

Country
ASPEN
Not Confirmed
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EJ Busuttil Ltd

Country
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ASPEN
Not Confirmed

Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution for Nebuliser

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2023-08-10

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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