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01 3ASTRAZENECA AB

02 2Ascend GmbH c/o Pollux Business Center GmbH

03 21Astrazeneca Ab

04 5Astrazeneca Ag

05 4Aurobindo Pharma (Malta) Limited

06 1Aurovitas Spain, Sau

07 1Cipla Europe N.V.

08 3Krka D.D. Novo Mesto

09 2Krka Dd, Novo Mesto

10 2Macleods Pharma Espana Slu

11 5PharmaPath S.A.

12 1Saba Ilac San. Ve Tic. A.?.

13 2Teva Bv

14 3Viatris Limited

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dapagliflozin

Brand Name : Forxiga

Dosage Form : Dapagliflozin 10Mg 28 Units 10Mg Oral Use

Dosage Strength : 28 cpr riv 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dapagliflozin; Metformin

Brand Name : Xigduo

Dosage Form : Dapagliflozin+Metformin+8505 Mg 56 Combined Oral Use

Dosage Strength : 56 cpr riv 5 mg + 850 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dapagliflozin; Metformin

Brand Name : Xigduo

Dosage Form : Dapagliflozin+Metformin+10005 Mg 56 Combined Oral Use

Dosage Strength : 56 cpr riv 5 mg + 1,000 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dapagliflozin; Saxagliptin

Brand Name : Qtern

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 26/06/2017

Application Number : 66040

Regulatory Info : Allowed

Registration Country : Switzerland

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Metformini Hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg;500mg

Packaging :

Approval Date : 16/07/2015

Application Number : 65377

Regulatory Info : Allowed

Registration Country : Switzerland

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Metformini Hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg;500mg

Packaging :

Approval Date : 16/07/2015

Application Number : 65377

Regulatory Info : Allowed

Registration Country : Switzerland

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Metformini Hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg;1000mg

Packaging :

Approval Date : 16/07/2015

Application Number : 65377

Regulatory Info : Allowed

Registration Country : Switzerland

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Metformini Hydrochloridum; Dapagliflozinum

Brand Name : Xigduo XR

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg;1000mg

Packaging :

Approval Date : 16/07/2015

Application Number : 65377

Regulatory Info : Allowed

Registration Country : Switzerland

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Dapagliflozin

Brand Name : Dapagliflozin Cipla

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-06-20

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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10

Ascend GmbH c/o Pollux Business Center G...

Country
IPPE
Not Confirmed
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Ascend GmbH c/o Pollux Business Center G...

Country
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IPPE
Not Confirmed

Dapagliflozin

Brand Name : Dapagliflozin Ascend

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-09-11

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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