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01 6Novartis Pharmaceuticals Corporation

02 1Viatris

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01

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FNCE
Not Confirmed

TELBIVUDINE

Brand Name : TYZEKA

Dosage Form : TABLET;ORAL

Dosage Strength : 600MG

Packaging :

Approval Date : 2006-10-25

Application Number : 22011

Regulatory Info : DISCN

Registration Country : USA

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02

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FNCE
Not Confirmed

TELBIVUDINE

Brand Name : TYZEKA

Dosage Form : SOLUTION;ORAL

Dosage Strength : 100MG/5ML

Packaging :

Approval Date : 2009-04-28

Application Number : 22154

Regulatory Info : DISCN

Registration Country : USA

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FNCE
Not Confirmed

Telbivudine

Brand Name : Sebivo

Dosage Form : Oral Solution

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 20/01/2009

Application Number : 20080314000037

Regulatory Info : Deregistered

Registration Country : Sweden

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FNCE
Not Confirmed

Telbivudine

Brand Name : Sebivo

Dosage Form : Film Coated Tablet

Dosage Strength : 600mg

Packaging :

Approval Date : 24/04/2007

Application Number : 20060313000078

Regulatory Info : Deregistered

Registration Country : Sweden

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05

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FNCE
Not Confirmed

Telbivudine

Brand Name : Sebivo

Dosage Form : Film Coated Tablet

Dosage Strength : 600MG

Packaging :

Approval Date : 2007-06-08

Application Number : 07388001

Regulatory Info : Cancelled

Registration Country : Spain

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FNCE
Not Confirmed

Telbivudine

Brand Name : Sebivo

Dosage Form : Oral Solution

Dosage Strength : 20MG

Packaging :

Approval Date : 2009-03-31

Application Number : 07388003

Regulatory Info : Cancelled

Registration Country : Spain

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FNCE
Not Confirmed
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FNCE
Not Confirmed

Telbivudine

Brand Name : Sebivo

Dosage Form : Film Coated Tablet

Dosage Strength : 600mg

Packaging :

Approval Date : 21/08/2006

Application Number : 57660

Regulatory Info : Allowed

Registration Country : Switzerland

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