01 1Adalvo Limited
02 2Alter Laboratories Sa
03 2Astellas Pharma Ag
04 3Astellas Pharma Europe B.V.
05 5Astellas Pharma Europe BV
06 6Astellas Pharma Europe Bv
07 1Avansor Pharma Oy
08 1Cinfa Laboratories Sa
09 1Clonmel Healthcare Limited
10 2Glenmark Arzneimittel Gmbh
11 1Normon Laboratories Sa
12 1Q Pharma Laboratories Sl
13 2Stada Pharmaceuticals Ag
14 1Stada Sl Laboratory
15 2Teva Gmbh
16 1Teva Pharma Slu
17 1Zentiva K.S.
18 3Zentiva Ks
01 34Mirabegron
02 2Mirabegronum
01 9Extended-Release Tablet
02 2Granules
03 2Prolonged Release Tablet
04 8Prolonged-Release Tablet
05 15Tablet
01 6Denmark
02 4Estonia
03 2Malta
04 5Norway
05 9Spain
06 8Sweden
07 2Switzerland
01 1Baxirto
02 16Betmiga
03 1Iretig
04 1Mirabegron Adalvo
05 1Mirabegron Advances
06 1Mirabegron Alter
07 1Mirabegron Cinfamed
08 1Mirabegron Clonmel
09 1Mirabegron Glenmark
10 1Mirabegron Normon
11 1Mirabegron Q Pharma
12 2Mirabegron Stada
13 2Mirabegron Teva
14 2Mirabegron Zentiva
15 1Mirabegron "Glenmark"
16 1Mirabegron "Stada"
17 1Mirabegron "Teva"
18 1Mirabegron "Zentiva"
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Betmiga
Dosage Form : Tablet
Dosage Strength : 25mg
Packaging :
Approval Date : 20/12/2012
Application Number : 20110922000140
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Betmiga
Dosage Form : Tablet
Dosage Strength : 50mg
Packaging :
Approval Date : 20/12/2012
Application Number : 20110922000157
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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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