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01 3Abacus Medicine

02 1Cherubino Limited

03 1EJ Busuttil Ltd

04 1Ebb Medical

05 9F. Hoffmann-La Roche

06 1Genentech

07 6Medartuum

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

COMPAMED
Not Confirmed
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COMPAMED
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

COMPAMED
Not Confirmed
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COMPAMED
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

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/09/2014

Application Number : 20140208000076

Regulatory Info : Deregistered

Registration Country : Sweden

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04

COMPAMED
Not Confirmed
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COMPAMED
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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05

COMPAMED
Not Confirmed
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COMPAMED
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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06

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/09/1993

Application Number : 19930904000029

Regulatory Info : Approved

Registration Country : Sweden

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07

COMPAMED
Not Confirmed
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COMPAMED
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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08

COMPAMED
Not Confirmed
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COMPAMED
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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09

COMPAMED
Not Confirmed
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COMPAMED
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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10

COMPAMED
Not Confirmed
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COMPAMED
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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11

COMPAMED
Not Confirmed
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COMPAMED
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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12

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 20/11/2013

Application Number : 20130228000019

Regulatory Info : Deregistered

Registration Country : Sweden

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13

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 25/02/2020

Application Number : 20191009000062

Regulatory Info : Deregistered

Registration Country : Sweden

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14

COMPAMED
Not Confirmed
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COMPAMED
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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15

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 29/01/2014

Application Number : 20130702000054

Regulatory Info : Approved

Registration Country : Sweden

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16

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 29/01/2014

Application Number : 20130702000078

Regulatory Info : Approved

Registration Country : Sweden

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17

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 17/12/2014

Application Number : 20140716000049

Regulatory Info : Approved

Registration Country : Sweden

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18

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 03/09/2014

Application Number : 20140208000083

Regulatory Info : Deregistered

Registration Country : Sweden

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19

Northern Medical Group Aps

Country
COMPAMED
Not Confirmed
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Northern Medical Group Aps

Country
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 19/10/2016

Application Number : 20160122000099

Regulatory Info : Deregistered

Registration Country : Sweden

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20

Omnia L?kemedel Ab

Country
COMPAMED
Not Confirmed
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Omnia L?kemedel Ab

Country
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COMPAMED
Not Confirmed

Dornas Alpha

Brand Name : Pulmozyme

Dosage Form : Inhalation Solution

Dosage Strength : 1mg/ml

Packaging :

Approval Date : 07/02/2013

Application Number : 20111214000060

Regulatory Info : Deregistered

Registration Country : Sweden

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