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01 1Adalvo Limited

02 2Alter Laboratories Sa

03 2Astellas Pharma Ag

04 5Astellas Pharma Europe BV

05 4Astellas Pharma Europe Bv

06 1Avansor Pharma Oy

07 1Cinfa Laboratories Sa

08 1Clonmel Healthcare Limited

09 1Glenmark Arzneimittel Gmbh

10 1Normon Laboratories Sa

11 1Stada Pharmaceuticals Ag

12 1Stada Sl Laboratory

13 1Teva Gmbh

14 1Teva Pharma Slu

15 2Zentiva Ks

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PharmaCompass

01

VMX
Not Confirmed
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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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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

VMX
Not Confirmed
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VMX
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
VMX
Not Confirmed
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Avansor Pharma Oy

Country
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VMX
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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