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01 1Olon S.p.A

02 18Takeda Pharmaceutical

03 1Viatris

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PharmaCompass

01

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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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03

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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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04

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Teduglutid

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 1.25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Teduglutid

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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teduglutide

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 125mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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teduglutide

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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08

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Teduglutide

Brand Name : Revestive

Dosage Form : Powder And Solvent For Injectable Solution

Dosage Strength : 5MG

Packaging :

Approval Date : 28-05-2013

Application Number : 12787001

Regulatory Info : Authorized

Registration Country : Spain

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09

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Teduglutide

Brand Name : Revestive

Dosage Form : Powder And Solvents For Solution For Injection

Dosage Strength : 1.25mg

Packaging :

Approval Date : 13-07-2017

Application Number : 28105807416

Regulatory Info : Prescription

Registration Country : Denmark

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10

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Teduglutide

Brand Name : Revestive

Dosage Form : Powder And Solvents For Solution For Injection

Dosage Strength : 5mg

Packaging :

Approval Date : 30-08-2012

Application Number : 28104848711

Regulatory Info : Prescription

Registration Country : Denmark

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11

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Teduglutide

Brand Name : Revestive

Dosage Form : Solution For Injection

Dosage Strength : 5mg

Packaging :

Approval Date : 30-08-2012

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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12

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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 : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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13

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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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14

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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15

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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16

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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17

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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18

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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19

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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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20

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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Teduglutide

Brand Name : Teduglutide Viatris

Dosage Form : Solution For Injection

Dosage Strength : 5mg

Packaging :

Approval Date : 08-01-2026

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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