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01 52Ipsen

02 4Medison Pharma

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PharmaCompass

01

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
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

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 1200mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 1200mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 200mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 200mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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09

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 400mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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10

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 400mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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11

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Bylvay

Dosage Form : Capsule

Dosage Strength : 600mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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12

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat

Brand Name : Kayfanda

Dosage Form : Capsule

Dosage Strength : 600mcg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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13

AMWC Asia-TDAC
Not Confirmed
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AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Hard Capsule

Dosage Strength : 1200MCG

Packaging :

Approval Date : 16-01-2025

Application Number : 1241854004

Regulatory Info : Authorized

Registration Country : Spain

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14

AMWC Asia-TDAC
Not Confirmed
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arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Bylvay

Dosage Form : Hard Capsule

Dosage Strength : 400MCG

Packaging :

Approval Date : 21-12-2021

Application Number : 1211566002

Regulatory Info : Authorized

Registration Country : Spain

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15

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Hard Capsule

Dosage Strength : 200MCG

Packaging :

Approval Date : 16-01-2025

Application Number : 1241854001

Regulatory Info : Authorized

Registration Country : Spain

blank

16

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Hard Capsule

Dosage Strength : 600MCG

Packaging :

Approval Date : 16-01-2025

Application Number : 1241854003

Regulatory Info : Authorized

Registration Country : Spain

blank

17

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Kayfanda

Dosage Form : Hard Capsule

Dosage Strength : 400MCG

Packaging :

Approval Date : 16-01-2025

Application Number : 1241854002

Regulatory Info : Authorized

Registration Country : Spain

blank

18

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Bylvay

Dosage Form : Hard Capsule

Dosage Strength : 200MCG

Packaging :

Approval Date : 21-12-2021

Application Number : 1211566001

Regulatory Info : Authorized

Registration Country : Spain

blank

19

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Bylvay

Dosage Form : Hard Capsule

Dosage Strength : 600MCG

Packaging :

Approval Date : 21-12-2021

Application Number : 1211566003

Regulatory Info : Authorized

Registration Country : Spain

blank

20

AMWC Asia-TDAC
Not Confirmed
arrow
arrow
AMWC Asia-TDAC
Not Confirmed

Odevixibat Sesquihydrate

Brand Name : Bylvay

Dosage Form : Hard Capsule

Dosage Strength : 1200MCG

Packaging :

Approval Date : 21-12-2021

Application Number : 1211566004

Regulatory Info : Authorized

Registration Country : Spain

blank