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01 22Care4 Aps

02 42care4 ApS

03 1ALFASIGMA SPA

04 1Alfasigma Spa

05 1COOPER S.A. Pharmaceuticals

06 1Ebb Medical Ab

07 3FARMIGEA SpA

08 1Farmalider Sa

09 1Farmigea S.p.A

10 5Horus Pharma

11 1Horus Pharma Suisse Sa

12 1Laboratoires THEA

13 3Laboratoires Théa SAS

14 1MYLAN SPA

15 1MYLAN SpA

16 2Medartuum Ab

17 2Nutra Essential Otc Sl

18 3Omnivision Ag

19 4Orifarm AS

20 3Orifarm Ab

21 1Paranova Pharmaceuticals Ab

22 1Pharma Stulln Gmbh

23 1S.F.GROUP Srl

24 2SIGMATAU IND.FARM.RIUNITE SpA

25 2SO.SE.PHARM Srl

26 1Sandoz Pharmaceuticals Ag

27 1Sopharma Ad

28 12Thea Laboratories

29 1Thea Pharma Sa

30 3Thea Sas Laboratories

31 2World Medicine Ilac San ve tic LTD STl

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
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Ketotifenhydrogenfumarat

Brand Name : Zaditen

Dosage Form : Eye Drops 

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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02

ASPEN
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ASPEN
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Ketotifenhydrogenfumarat

Brand Name : Zaditen

Dosage Form : Eye Drops 

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

ASPEN
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ASPEN
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Ketotifenhydrogenfumarat

Brand Name : Zaditen

Dosage Form : Eye Drops 

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ketotifenhydrogenfumarat

Brand Name : Zaditen

Dosage Form : Eye Drops 

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Ketotifen Hydrogen Fumarate

Brand Name : Zaditen

Dosage Form : Eye Drops

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date : 07-08-2015

Application Number : 28105608415

Regulatory Info : Prescription

Registration Country : Denmark

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06

ASPEN
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ASPEN
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Ketotifen Hydrogen Fumarate

Brand Name : Zaditen

Dosage Form : Eye Drops

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date : 29-09-2015

Application Number : 28105660915

Regulatory Info : Prescription

Registration Country : Denmark

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07

ASPEN
Not Confirmed
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ASPEN
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Ketotifen

Brand Name : ZADITEN

Dosage Form : Extended Release Tablets

Dosage Strength : 2 mg

Packaging : 15 UNITS 2 MG - ORAL USE (PROLONGED RELEASE)

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

ASPEN
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ASPEN
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Ketotifen

Brand Name : Forest

Dosage Form : Oral Solution

Dosage Strength : 0.2MG

Packaging :

Approval Date : 01-02-1982

Application Number : 55805

Regulatory Info : Authorized

Registration Country : Spain

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09

ASPEN
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Ketotifen

Brand Name : Cleroptic Eye

Dosage Form : Eye Drop Solution

Dosage Strength : 0.25MG

Packaging :

Approval Date : 2016-07-26

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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10

ASPEN
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Ketotifenv?tefumarate

Brand Name : The Zadit

Dosage Form : Eye Drop

Dosage Strength : 0.25mg/ml

Packaging :

Approval Date : 14/02/2018

Application Number : 20170407000058

Regulatory Info : Deregistered

Registration Country : Sweden

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