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01 1Adalvo Limited

02 2Alter Laboratories Sa

03 2Astellas Pharma Ag

04 3Astellas Pharma Europe B.V.

05 5Astellas Pharma Europe BV

06 4Astellas Pharma Europe Bv

07 1Avansor Pharma Oy

08 1Cinfa Laboratories Sa

09 1Clonmel Healthcare Limited

10 1Glenmark Arzneimittel Gmbh

11 1Normon Laboratories Sa

12 1Stada Pharmaceuticals Ag

13 1Stada Sl Laboratory

14 1Teva Gmbh

15 1Teva Pharma Slu

16 1Zentiva K.S.

17 2Zentiva Ks

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Betmiga

Dosage Form : Tablet

Dosage Strength : 25mg

Packaging :

Approval Date : 20/12/2012

Application Number : 20110922000140

Regulatory Info : Approved

Registration Country : Sweden

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Betmiga

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 20/12/2012

Application Number : 20110922000157

Regulatory Info : Approved

Registration Country : Sweden

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Betmiga

Dosage Form : Granules

Dosage Strength : 8mg/ml

Packaging :

Approval Date : 24/08/2024

Application Number : 20211123000073

Regulatory Info : Approved

Registration Country : Sweden

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegronum

Brand Name : Betmiga

Dosage Form : Prolonged Release Tablet

Dosage Strength : 25mg

Packaging :

Approval Date : 19/05/2014

Application Number : 62755

Regulatory Info : Allowed

Registration Country : Switzerland

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegronum

Brand Name : Betmiga

Dosage Form : Prolonged Release Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 19/05/2014

Application Number : 62755

Regulatory Info : Allowed

Registration Country : Switzerland

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Mirabegron Glenmark

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 03/09/2024

Application Number : 20230703000036

Regulatory Info : Approved

Registration Country : Sweden

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Mirabegron Stada

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 04/09/2024

Application Number : 20231227000045

Regulatory Info : Approved

Registration Country : Sweden

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Mirabegron Teva

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 03/09/2024

Application Number : 20231227000021

Regulatory Info : Approved

Registration Country : Sweden

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Mirabegron

Brand Name : Mirabegron Zentiva

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 03/09/2024

Application Number : 20230703000029

Regulatory Info : Approved

Registration Country : Sweden

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10

Avansor Pharma Oy

Country
IPPE
Not Confirmed
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Avansor Pharma Oy

Country
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IPPE
Not Confirmed

Mirabegron

Brand Name : Mirabegron Advances

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 27/01/2025

Application Number : 20231227000014

Regulatory Info : Approved

Registration Country : Sweden

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