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01 8Advanz Pharma

02 3Amdipharm Mercury Debtco Limited

03 2Apotex Inc

04 3Intas Pharmaceuticals

05 2Intercept Pharmaceuticals

06 2Lupin Ltd

07 2MSN Laboratories

08 2ORIFARM GROUP AS

09 1Optimus Pharma

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PharmaCompass

01

ESF Europe
Not Confirmed
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ESF Europe
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

ESF Europe
Not Confirmed
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ESF Europe
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

ESF Europe
Not Confirmed
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ESF Europe
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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04

ESF Europe
Not Confirmed
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ESF Europe
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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05

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2463121

Regulatory Info : Prescription

Registration Country : Canada

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06

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2463148

Regulatory Info : Prescription

Registration Country : Canada

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07

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214862

Regulatory Info : DISCN

Registration Country : USA

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08

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214862

Regulatory Info : DISCN

Registration Country : USA

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09

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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11

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

Obeticholic Acid

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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12

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2016-05-27

Application Number : 207999

Regulatory Info : DISCN

Registration Country : USA

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13

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OCALIVA

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2016-05-27

Application Number : 207999

Regulatory Info : DISCN

Registration Country : USA

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14

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214980

Regulatory Info : DISCN

Registration Country : USA

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15

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 214980

Regulatory Info : DISCN

Registration Country : USA

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16

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-30

Application Number : 215017

Regulatory Info : DISCN

Registration Country : USA

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17

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-30

Application Number : 215017

Regulatory Info : DISCN

Registration Country : USA

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18

ESF Europe
Not Confirmed
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ESF Europe
Not Confirmed

OBETICHOLIC ACID

Brand Name : OBETICHOLIC ACID

Dosage Form : TABLET; ORAL

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number : 214935

Regulatory Info :

Registration Country : USA

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19

ESF Europe
Not Confirmed
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ESF Europe
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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20

ESF Europe
Not Confirmed
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ESF Europe
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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