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01 10Janssen-Cilag

02 3Johnson & Johnson Innovative Medicine

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PharmaCompass

01

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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

BD&L Summit
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BD&L Summit
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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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11

BD&L Summit
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BD&L Summit
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BEDAQUILINE FUMARATE

Brand Name : SIRTURO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2012-12-28

Application Number : 204384

Regulatory Info : RX

Registration Country : USA

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12

BD&L Summit
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BD&L Summit
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BEDAQUILINE FUMARATE

Brand Name : SIRTURO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2020-05-27

Application Number : 204384

Regulatory Info : RX

Registration Country : USA

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13

BD&L Summit
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BD&L Summit
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Bedaquiline

Brand Name : SIRTURO

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 188X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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