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01 1JANSSEN CILAG INTERNAT.N.V.

02 2Janssen - Cilag International

03 2Janssen-Cilag International N.V.

04 1Janssen-Cilag International NV

05 4Janssen-Cilag International Nv

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PharmaCompass

01

DCAT Week
Not Confirmed
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DCAT Week
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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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02

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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04

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 20mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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05

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 10-09-2015

Application Number : 113901002

Regulatory Info : Authorized

Registration Country : Spain

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06

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 18-09-2014

Application Number : 113901001

Regulatory Info : Authorized

Registration Country : Spain

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07

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquilin Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 05-03-2014

Application Number : 28105172412

Regulatory Info : Prescription

Registration Country : Denmark

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08

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquilin Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 26-03-2021

Application Number : 28106375419

Regulatory Info : Prescription

Registration Country : Denmark

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09

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 05-03-2014

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

DCAT Week
Not Confirmed
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DCAT Week
Not Confirmed

Bedaquiline Fumarate

Brand Name : Sirturo

Dosage Form : Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 26-03-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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