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01 4Pharmathen SA

02 3Abacus Medicine

03 3Accord healthcare

04 2Amarox Pharma Bv

05 2Amneal Pharma Europe Limited

06 2Aurovitas Spain, Sau

07 6Bristol Myers Squibb

08 2Cipla

09 3Ebb Medical

10 2Fresenius Kabi AB Brunna

11 2GSK

12 2Glenmark Pharmaceuticals

13 2Medical Valley

14 1ORIFARM GROUP AS

15 2PharOS Ltd

16 6STADA Arzneimittel

17 6Sandoz B2B

18 2Sun Pharmaceutical Industries Limited

19 2Tarbis Farma Sl

20 6Teva Pharmaceutical Industries

21 2Tillomed Laboratories Ltd

22 3Viatris

23 2Zentiva

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : Prescription

Registration Country : Denmark

Entecavir (Monohydrate)

Brand Name : Edevira

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 29-09-2017

Application Number : 28105810016

Regulatory Info : Prescription

Registration Country : Denmark

Pharmathen

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : Prescription

Registration Country : Denmark

Entecavir (Monohydrate)

Brand Name : Entecavir \"Pharmathen\"

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 29-09-2017

Application Number : 28105809816

Regulatory Info : Prescription

Registration Country : Denmark

Pharmathen

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : Prescription

Registration Country : Denmark

Entecavir (Monohydrate)

Brand Name : Edevira

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 29-09-2017

Application Number : 28105810116

Regulatory Info : Prescription

Registration Country : Denmark

Pharmathen

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Regulatory Info : Prescription

Registration Country : Denmark

Entecavir (Monohydrate)

Brand Name : Entecavir \"Pharmathen\"

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 29-09-2017

Application Number : 28105809916

Regulatory Info : Prescription

Registration Country : Denmark

Pharmathen

05

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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11

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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12

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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13

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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14

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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15

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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16

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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18

SCOPE Summit
Not Confirmed
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SCOPE Summit
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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19

Amarox Pharma Bv

Country
SCOPE Summit
Not Confirmed
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Amarox Pharma Bv

Country
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SCOPE Summit
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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20

Amarox Pharma Bv

Country
SCOPE Summit
Not Confirmed
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Amarox Pharma Bv

Country
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SCOPE Summit
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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