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01 4Abacus Medicine A/S

02 1Cherubino Limited

03 1Cross Pharma Ab

04 1EJ Busuttil Ltd

05 1Ebb Medical Ab

06 1F. Hoffmann-La Roche, Ltd.

07 7Medartuum Ab

08 1Northern Medical Group Aps

09 1Omnia L?kemedel Ab

10 6Orifarm Ab

11 5Paranova Pharmaceuticals Ab

12 2Pharmachim Ab

13 1Roche Ab

14 1Roche Eesti Osaühing

15 1Roche Farma Sa

16 1Roche Norge AS

17 1Roche Pharma (Switzerland) Ag

18 1Roche Pharmaceuticals A/S

19 1Roche Products Limited

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PharmaCompass

01

BePharma
Not Confirmed
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BePharma
Not Confirmed

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

BePharma
Not Confirmed
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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03-09-2014

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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03

BePharma
Not Confirmed
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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21-12-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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04

BePharma
Not Confirmed
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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 21-12-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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05

BePharma
Not Confirmed
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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03-07-2024

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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06

BePharma
Not Confirmed
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BePharma
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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07

BePharma
Not Confirmed
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BePharma
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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08

BePharma
Not Confirmed
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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03-09-2014

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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09

Cherubino Limited

Country
BePharma
Not Confirmed
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Cherubino Limited

Country
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BePharma
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
BePharma
Not Confirmed
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EJ Busuttil Ltd

Country
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BePharma
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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