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01 2Accord Healthcare Slu

02 2Amarox Pharma Bv

03 2Amneal Pharma Europe Limited

04 2Aurovitas Spain, Sau

05 3Bristol-Myers Squibb Pharma Eeig

06 2Cipla Europe

07 3Ebb Medical Ab

08 2Fresenius Kabi Espa?a, Sau

09 4Glenmark Arzneimittel Gmbh

10 2Medical Valley Invest Ab

11 2PharOS – Pharmaceutical Oriented Services Limited

12 2Sandoz A/S

13 2Sandoz Pharmaceuticals Sa

14 2Stada Pharmaceuticals Ag

15 2Stada Sl Laboratory

16 2Sun Pharmaceutical Industries (Europe) Bv

17 2Tarbis Farma Sl

18 2Teva Pharma Slu

19 2Teva Sweden Ab

20 2Tillomed Spain Laboratories Sl

21 2Viatris Limited

22 2Zentiva Ks

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Accord

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 26/09/2017

Application Number : 20160723000030

Regulatory Info : Approved

Registration Country : Sweden

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Accord

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 26/09/2017

Application Number : 20160723000047

Regulatory Info : Approved

Registration Country : Sweden

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Baraclude

Dosage Form : Oral Solution

Dosage Strength : 0.05mg/ml

Packaging :

Approval Date : 26/06/2006

Application Number : 20041007000031

Regulatory Info : Approved

Registration Country : Sweden

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04

CTAD25
Not Confirmed
arrow
arrow
CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Baraclude

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 26/06/2006

Application Number : 20041007000017

Regulatory Info : Approved

Registration Country : Sweden

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05

CTAD25
Not Confirmed
arrow
arrow
CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Baraclude

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 26/06/2006

Application Number : 20041007000024

Regulatory Info : Approved

Registration Country : Sweden

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06

CTAD25
Not Confirmed
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arrow
CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Amarox

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 13/02/2025

Application Number : 20241108000057

Regulatory Info : Approved

Registration Country : Sweden

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07

CTAD25
Not Confirmed
arrow
arrow
CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Amarox

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 13/02/2025

Application Number : 20241108000064

Regulatory Info : Approved

Registration Country : Sweden

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Medical Valley

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 26/06/2019

Application Number : 20180425000015

Regulatory Info : Approved

Registration Country : Sweden

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09

Amarox Pharma Bv

Country
CTAD25
Not Confirmed
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Amarox Pharma Bv

Country
arrow
CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Amarox

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 28/05/2021

Application Number : 20180409000024

Regulatory Info : Approved

Registration Country : Sweden

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10

Amarox Pharma Bv

Country
CTAD25
Not Confirmed
arrow

Amarox Pharma Bv

Country
arrow
CTAD25
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Amarox

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 28/05/2021

Application Number : 20180409000031

Regulatory Info : Approved

Registration Country : Sweden

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