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01 4Abacus Medicine

02 1Cherubino Limited

03 1EJ Busuttil Ltd

04 1Ebb Medical

05 12F. Hoffmann-La Roche

06 1Genentech

07 7Medartuum

08 1Northern Medical Group Aps

09 6ORIFARM GROUP AS

10 1Omnia L?kemedel Ab

11 5Paranova Pharmaceuticals Ab

12 2Pharmachim Ab

13 1Unimedic AB

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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

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

BePharma
Not Confirmed
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BePharma
Not Confirmed

Dornase Alfa

Brand Name : Pulmozyme

Dosage Form : Solution for Nebuliser

Dosage Strength : 1000UNIT/ML

Packaging :

Approval Date : 2006-04-10

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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04

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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05

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 :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

BePharma
Not Confirmed
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BePharma
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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07

BePharma
Not Confirmed
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BePharma
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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08

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 : 23-02-1994

Application Number : 28101546293

Regulatory Info : Prescription

Registration Country : Denmark

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09

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 : 03-09-1993

Application Number : 1.99E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

BePharma
Not Confirmed
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BePharma
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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11

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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12

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 : 20-11-2013

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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13

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 : 20-11-2013

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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14

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 : 29-01-2014

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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15

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 : 29-01-2014

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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16

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 : 29-01-2014

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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17

Cherubino Limited

Country
BePharma
Not Confirmed
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Cherubino Limited

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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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18

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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19

Omnia L?kemedel Ab

Country
BePharma
Not Confirmed
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Omnia L?kemedel Ab

Country
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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 07-02-2013

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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20

Paranova Pharmaceuticals Ab

Country
BePharma
Not Confirmed
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Paranova Pharmaceuticals Ab

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BePharma
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 30-10-2012

Application Number : 2.01E+13

Regulatory Info : Deregistered

Registration Country : Sweden

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