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    Bedaquiline (fumarate)

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    01 1JANSSEN CILAG INTERNAT.N.V.

    02 3Janssen-Cilag International N.V.

    03 2Janssen-Cilag International Nv

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    01

    JANSSEN CILAG INTERNAT.N.V.

    Italy
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    JANSSEN CILAG INTERNAT.N.V.

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Bedaquiline

    Brand Name : Sirturo

    Dosage Form : Bedaquilina 100Mg 188 Unita' Oral Use

    Dosage Strength : 188 CPR 100 mg bottle

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Janssen-Cilag International N.V.

    Italy
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    Janssen-Cilag International N.V.

    Italy
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    Regulatory Info :

    Registration Country : Norway

    Bedaquiline

    Brand Name : Sirturo

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 100 mg

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    Janssen-Cilag International Nv

    Italy
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    Regulatory Info : Approved

    Registration Country : Sweden

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 100mg

    Packaging :

    Approval Date : 05/03/2014

    Application Number : 20120908000088

    Regulatory Info : Approved

    Registration Country : Sweden

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    04

    Janssen-Cilag International Nv

    Italy
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    Regulatory Info : Approved

    Registration Country : Sweden

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 20mg

    Packaging :

    Approval Date : 26/03/2021

    Application Number : 20191127000036

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Janssen-Cilag International N.V.

    Italy
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    Janssen-Cilag International N.V.

    Italy
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    Regulatory Info : Authorized

    Registration Country : Spain

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2015-09-10

    Application Number : 113901002

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Janssen-Cilag International N.V.

    Italy
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    Janssen-Cilag International N.V.

    Italy
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    Regulatory Info : Authorized

    Registration Country : Spain

    Bedaquiline Fumarate

    Brand Name : Sirturo

    Dosage Form : Tablet

    Dosage Strength : 100MG

    Packaging :

    Approval Date : 2014-09-18

    Application Number : 113901001

    Regulatory Info : Authorized

    Registration Country : Spain

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