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01 20Ipsen

02 4MEDISON PHARMA CANADA INC.

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PharmaCompass

01

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

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

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02

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

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

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03

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

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

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04

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

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

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05

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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06

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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07

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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08

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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09

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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10

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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11

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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12

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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13

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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14

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
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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15

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
Not Confirmed

Odevixibat Sesquihydrate

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

blank

16

Fall Technical Meeting
Not Confirmed
arrow
arrow
Fall Technical Meeting
Not Confirmed

Odevixibat Sesquihydrate

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

blank

17

MEDISON PHARMA CANADA INC.

Country
Fall Technical Meeting
Not Confirmed
arrow

MEDISON PHARMA CANADA INC.

Country
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE

Dosage Strength : 200MCG

Packaging :

Approval Date :

Application Number : 2542641

Regulatory Info : Prescription

Registration Country : Canada

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18

MEDISON PHARMA CANADA INC.

Country
Fall Technical Meeting
Not Confirmed
arrow

MEDISON PHARMA CANADA INC.

Country
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE

Dosage Strength : 400MCG

Packaging :

Approval Date :

Application Number : 2542676

Regulatory Info : Prescription

Registration Country : Canada

blank

19

MEDISON PHARMA CANADA INC.

Country
Fall Technical Meeting
Not Confirmed
arrow

MEDISON PHARMA CANADA INC.

Country
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE

Dosage Strength : 600MCG

Packaging :

Approval Date :

Application Number : 2542684

Regulatory Info : Prescription

Registration Country : Canada

blank

20

MEDISON PHARMA CANADA INC.

Country
Fall Technical Meeting
Not Confirmed
arrow

MEDISON PHARMA CANADA INC.

Country
arrow
Fall Technical Meeting
Not Confirmed

ODEVIXIBAT

Brand Name : BYLVAY

Dosage Form : CAPSULE

Dosage Strength : 1200MCG

Packaging :

Approval Date :

Application Number : 2542692

Regulatory Info : Prescription

Registration Country : Canada

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