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01 1Olon S.p.A

02 1SHIRE PLC

03 6Takeda Pharmaceutical

04 6Takeda Pharmaceuticals Australia Pty. Ltd.

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PharmaCompass

01

FNCE
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Teduglutide Recombinant

Brand Name :

Dosage Form : Lyophilizate

Dosage Strength : 5MG

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info : Available Dossier- US

Registration Country : Italy

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02

FNCE
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FNCE
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Teduglutide Recombinant

Brand Name : Revestive

Dosage Form : Powder and liquid to the injection fluid, resolution

Dosage Strength : 5 mg

Packaging : Set

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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03

FNCE
Not Confirmed
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FNCE
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TEDUGLUTIDE

Brand Name : GATTEX KIT

Dosage Form : POWDER;SUBCUTANEOUS

Dosage Strength : 5MG/VIAL

Packaging :

Approval Date : 2012-12-21

Application Number : 203441

Regulatory Info : RX

Registration Country : USA

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04

FNCE
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FNCE
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Teduglutide

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 1.25mg

Packaging :

Approval Date : 23/06/2017

Application Number : 20160705000065

Regulatory Info : Approved

Registration Country : Sweden

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05

FNCE
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FNCE
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Teduglutide

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 5mg

Packaging :

Approval Date : 30/08/2012

Application Number : 20110412000049

Regulatory Info : Approved

Registration Country : Sweden

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06

FNCE
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FNCE
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Teduglutide

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 5mg/5ml

Packaging :

Approval Date : 01/09/2016

Application Number : 65739

Regulatory Info : Allowed

Registration Country : Switzerland

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07

FNCE
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FNCE
Not Confirmed

TEDUGLUTIDE

Brand Name : REVESTIVE

Dosage Form : KIT

Dosage Strength : 5MG/VIAL

Packaging : 28X5MG VIALS & 28X0.5ML PFS

Approval Date :

Application Number : 2445727

Regulatory Info : Schedule D

Registration Country : Canada

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08

FNCE
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FNCE
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Teduglutide

Brand Name : Revestive

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 5MG

Packaging :

Approval Date : 2013-05-28

Application Number : 12787001

Regulatory Info : Authorized

Registration Country : Spain

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09

Takeda Pharmaceuticals Australia Pt...

Country
FNCE
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Takeda Pharmaceuticals Australia Pt...

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FNCE
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Teduglutide

Brand Name : Revestive

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Takeda Pharmaceuticals Australia Pt...

Country
FNCE
Not Confirmed
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Takeda Pharmaceuticals Australia Pt...

Country
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FNCE
Not Confirmed

Teduglutide

Brand Name : Revestive

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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11

Takeda Pharmaceuticals Australia Pt...

Country
FNCE
Not Confirmed
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Takeda Pharmaceuticals Australia Pt...

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FNCE
Not Confirmed

Teduglutide

Brand Name : Revestive

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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12

Takeda Pharmaceuticals Australia Pt...

Country
FNCE
Not Confirmed
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Takeda Pharmaceuticals Australia Pt...

Country
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FNCE
Not Confirmed

Teduglutide

Brand Name : Revestive

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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13

Takeda Pharmaceuticals Australia Pt...

Country
FNCE
Not Confirmed
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Takeda Pharmaceuticals Australia Pt...

Country
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FNCE
Not Confirmed

Teduglutide

Brand Name : Revestive

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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14

Takeda Pharmaceuticals Australia Pt...

Country
FNCE
Not Confirmed
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Takeda Pharmaceuticals Australia Pt...

Country
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FNCE
Not Confirmed

Teduglutide

Brand Name : Revestive

Dosage Form :

Dosage Strength :

Packaging : 28

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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