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01 20Ipsen
02 4MEDISON PHARMA CANADA INC.
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01 4CAPSULE
02 2CAPSULE, PELLETS;ORAL
03 2CAPSULE;ORAL
04 8Capsule
05 8Hard Capsule
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01 8Approved
02 8Authorized
03 4Prescription
04 4RX
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01 8BYLVAY
02 8Bylvay
03 8Kayfanda
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01 4Canada
02 8Spain
03 8Sweden
04 4USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BYLVAY
Dosage Form : CAPSULE, PELLETS;ORAL
Dosage Strength : 0.2MG
Packaging :
Approval Date : 2021-07-20
Application Number : 215498
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BYLVAY
Dosage Form : CAPSULE;ORAL
Dosage Strength : 0.4MG
Packaging :
Approval Date : 2021-07-20
Application Number : 215498
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BYLVAY
Dosage Form : CAPSULE, PELLETS;ORAL
Dosage Strength : 0.6MG
Packaging :
Approval Date : 2021-07-20
Application Number : 215498
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BYLVAY
Dosage Form : CAPSULE;ORAL
Dosage Strength : 1.2MG
Packaging :
Approval Date : 2021-07-20
Application Number : 215498
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bylvay
Dosage Form : Capsule
Dosage Strength : 1200mcg
Packaging :
Approval Date : 16/07/2021
Application Number : 20201109000104
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bylvay
Dosage Form : Capsule
Dosage Strength : 200mcg
Packaging :
Approval Date : 16/07/2021
Application Number : 20201109000074
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bylvay
Dosage Form : Capsule
Dosage Strength : 400mcg
Packaging :
Approval Date : 16/07/2021
Application Number : 20201109000081
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bylvay
Dosage Form : Capsule
Dosage Strength : 600mcg
Packaging :
Approval Date : 16/07/2021
Application Number : 20201109000098
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kayfanda
Dosage Form : Capsule
Dosage Strength : 1200mcg
Packaging :
Approval Date : 20/09/2024
Application Number : 20231127000107
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kayfanda
Dosage Form : Capsule
Dosage Strength : 200mcg
Packaging :
Approval Date : 20/09/2024
Application Number : 20231127000077
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kayfanda
Dosage Form : Capsule
Dosage Strength : 400mcg
Packaging :
Approval Date : 20/09/2024
Application Number : 20231127000084
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kayfanda
Dosage Form : Capsule
Dosage Strength : 600mcg
Packaging :
Approval Date : 20/09/2024
Application Number : 20231127000091
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kayfanda
Dosage Form : Hard Capsule
Dosage Strength : 1200MCG
Packaging :
Approval Date : 2025-01-16
Application Number : 1241854004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Bylvay
Dosage Form : Hard Capsule
Dosage Strength : 400MCG
Packaging :
Approval Date : 2021-12-21
Application Number : 1211566002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kayfanda
Dosage Form : Hard Capsule
Dosage Strength : 200MCG
Packaging :
Approval Date : 2025-01-16
Application Number : 1241854001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kayfanda
Dosage Form : Hard Capsule
Dosage Strength : 600MCG
Packaging :
Approval Date : 2025-01-16
Application Number : 1241854003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BYLVAY
Dosage Form : CAPSULE
Dosage Strength : 200MCG
Packaging :
Approval Date :
Application Number : 2542641
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BYLVAY
Dosage Form : CAPSULE
Dosage Strength : 400MCG
Packaging :
Approval Date :
Application Number : 2542676
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BYLVAY
Dosage Form : CAPSULE
Dosage Strength : 600MCG
Packaging :
Approval Date :
Application Number : 2542684
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : BYLVAY
Dosage Form : CAPSULE
Dosage Strength : 1200MCG
Packaging :
Approval Date :
Application Number : 2542692
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF