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01 16Ipsen Pharma

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 1200mcg

Packaging :

Approval Date : 16/07/2021

Application Number : 20201109000104

Regulatory Info : Approved

Registration Country : Sweden

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 200mcg

Packaging :

Approval Date : 16/07/2021

Application Number : 20201109000074

Regulatory Info : Approved

Registration Country : Sweden

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 400mcg

Packaging :

Approval Date : 16/07/2021

Application Number : 20201109000081

Regulatory Info : Approved

Registration Country : Sweden

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04

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 600mcg

Packaging :

Approval Date : 16/07/2021

Application Number : 20201109000098

Regulatory Info : Approved

Registration Country : Sweden

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05

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 1200mcg

Packaging :

Approval Date : 20/09/2024

Application Number : 20231127000107

Regulatory Info : Approved

Registration Country : Sweden

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06

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 200mcg

Packaging :

Approval Date : 20/09/2024

Application Number : 20231127000077

Regulatory Info : Approved

Registration Country : Sweden

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07

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 400mcg

Packaging :

Approval Date : 20/09/2024

Application Number : 20231127000084

Regulatory Info : Approved

Registration Country : Sweden

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibate Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 600mcg

Packaging :

Approval Date : 20/09/2024

Application Number : 20231127000091

Regulatory Info : Approved

Registration Country : Sweden

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09

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibat Sesquihydrate

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

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10

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

Odevixibat Sesquihydrate

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

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