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01 2Accord healthcare

02 2Amarox Pharma Bv

03 2Amneal Pharma Europe Limited

04 2Aurovitas Spain, Sau

05 3Bristol Myers Squibb

06 2Cipla

07 3Ebb Medical

08 2Fresenius Kabi AB Brunna

09 2GSK

10 2Glenmark Pharmaceuticals

11 2Medical Valley

12 4STADA Arzneimittel

13 4Sandoz B2B

14 2Sun Pharmaceutical Industries Limited

15 2Tarbis Farma Sl

16 4Teva Pharmaceutical Industries

17 2Tillomed Laboratories Ltd

18 2Viatris

19 2Zentiva

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PharmaCompass

01

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
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

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Ebb

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 31/07/2019

Application Number : 20190514000048

Regulatory Info : Approved

Registration Country : Sweden

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09

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Glenmark

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 16/06/2017

Application Number : 20160630000079

Regulatory Info : Deregistered

Registration Country : Sweden

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10

AusBiotech
Not Confirmed
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AusBiotech
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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11

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Sandoz

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 12/05/2017

Application Number : 20160705000010

Regulatory Info : Approved

Registration Country : Sweden

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12

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Sandoz

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 12/05/2017

Application Number : 20160705000027

Regulatory Info : Approved

Registration Country : Sweden

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13

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Stada

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 19/05/2017

Application Number : 20160630000055

Regulatory Info : Approved

Registration Country : Sweden

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14

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Stada

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 19/05/2017

Application Number : 20160630000062

Regulatory Info : Approved

Registration Country : Sweden

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15

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Viatris

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 18/09/2017

Application Number : 20160701000137

Regulatory Info : Approved

Registration Country : Sweden

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16

AusBiotech
Not Confirmed
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Viatris

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 18/09/2017

Application Number : 20160701000144

Regulatory Info : Approved

Registration Country : Sweden

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17

Amarox Pharma Bv

Country
AusBiotech
Not Confirmed
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Amarox Pharma Bv

Country
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AusBiotech
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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18

Amarox Pharma Bv

Country
AusBiotech
Not Confirmed
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Amarox Pharma Bv

Country
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AusBiotech
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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19

Amneal Pharma Europe Limited

Country
AusBiotech
Not Confirmed
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Amneal Pharma Europe Limited

Country
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Amneal

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 08/09/2017

Application Number : 20160706000019

Regulatory Info : Deregistered

Registration Country : Sweden

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20

Amneal Pharma Europe Limited

Country
AusBiotech
Not Confirmed
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Amneal Pharma Europe Limited

Country
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AusBiotech
Not Confirmed

Entekavirmonohydrat

Brand Name : Entecavir Amneal

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 08/09/2017

Application Number : 20160706000026

Regulatory Info : Deregistered

Registration Country : Sweden

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