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01 4Advanz Pharma Limited

02 2Advanz Pharma Specialty Medicine Switzerland Gmbh

03 2Orifarm AS

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PharmaCompass

01

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IPPE
Not Confirmed

Obeticholic Acid

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 01/06/2018

Application Number : 66530

Regulatory Info : Allowed

Registration Country : Switzerland

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02

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IPPE
Not Confirmed

Obeticholic Acid

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 01/06/2018

Application Number : 66530

Regulatory Info : Allowed

Registration Country : Switzerland

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obeticholsyra

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 12/12/2016

Application Number : 20150613000028

Regulatory Info : Deregistered

Registration Country : Sweden

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obeticholsyra

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 12/12/2016

Application Number : 20150613000011

Regulatory Info : Deregistered

Registration Country : Sweden

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obeticholic Acid

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 31-01-2017

Application Number : 1161139002

Regulatory Info : Cancelled

Registration Country : Spain

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obeticholic Acid

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 31-01-2017

Application Number : 1161139001

Regulatory Info : Cancelled

Registration Country : Spain

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obeticholic

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Obeticholic

Brand Name : Ocaliva

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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