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01 4Alexion Pharmaceuticals
02 12AstraZeneca
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01 2CAP
02 2CAPSULE; ORAL
03 2CAPSULE;ORAL
04 2Capsule
05 2GRANULE;ORAL
06 4Hard Capsule
07 2Blank
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01 2Allowed
02 2Approved
03 2Authorized
04 2Originator
05 2RX
06 6Blank
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01 6KOSELUGO
02 2Kiss Logo
03 8Koselugo
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01 2Australia
02 2South Africa
03 2Spain
04 2Sweden
05 2Switzerland
06 6USA
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Koselugo
Dosage Form : Hard Capsule
Dosage Strength : 10mg
Packaging :
Approval Date : 29/07/2022
Application Number : 67410
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Koselugo
Dosage Form : Hard Capsule
Dosage Strength : 25mg
Packaging :
Approval Date : 29/07/2022
Application Number : 67410
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Koselugo
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Koselugo
Dosage Form :
Dosage Strength :
Packaging : 60
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : KOSELUGO
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 10MG BASE
Packaging :
Approval Date : 2020-04-10
Application Number : 213756
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : KOSELUGO
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 25MG BASE
Packaging :
Approval Date : 2020-04-10
Application Number : 213756
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : KOSELUGO
Dosage Form : GRANULE;ORAL
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number : 219943
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : KOSELUGO
Dosage Form : GRANULE;ORAL
Dosage Strength : 7.5mg
Packaging :
Approval Date :
Application Number : 219943
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : KOSELUGO
Dosage Form : CAPSULE; ORAL
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 219943
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : KOSELUGO
Dosage Form : CAPSULE; ORAL
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number : 219943
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kiss Logo
Dosage Form : Capsule
Dosage Strength : 10mg
Packaging :
Approval Date : 17/06/2021
Application Number : 20200310000040
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kiss Logo
Dosage Form : Capsule
Dosage Strength : 25mg
Packaging :
Approval Date : 17/06/2021
Application Number : 20200310000057
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Koselugo
Dosage Form : CAP
Dosage Strength : 10mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Koselugo
Dosage Form : CAP
Dosage Strength : 25mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Koselugo
Dosage Form : Hard Capsule
Dosage Strength : 25MG
Packaging :
Approval Date : 2021-07-27
Application Number : 1211552002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Koselugo
Dosage Form : Hard Capsule
Dosage Strength : 10MG
Packaging :
Approval Date : 2021-07-27
Application Number : 1211552001
Regulatory Info : Authorized
Registration Country : Spain