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01 5Centocor

02 12Janssen-Cilag

03 5Johnson & Johnson Innovative Medicine

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PharmaCompass

01

AAPS
Not Confirmed
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AAPS
Not Confirmed

GUSELKUMAB

Brand Name : TREMFYA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/ML

Packaging :

Approval Date :

Application Number : 761061

Regulatory Info :

Registration Country : USA

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02

AAPS
Not Confirmed
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AAPS
Not Confirmed

GUSELKUMAB

Brand Name : TREMFYA

Dosage Form : SOLUTION

Dosage Strength : 100MG/1ML

Packaging : 1ML

Approval Date :

Application Number : 2469758

Regulatory Info : Schedule D

Registration Country : Canada

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03

AAPS
Not Confirmed
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AAPS
Not Confirmed

GUSELKUMAB

Brand Name : TREMFYA ONE-PRESS

Dosage Form : SOLUTION

Dosage Strength : 100MG/1ML

Packaging :

Approval Date :

Application Number : 2487314

Regulatory Info : Schedule D

Registration Country : Canada

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04

AAPS
Not Confirmed
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AAPS
Not Confirmed

GUSELKUMAB

Brand Name : TREMFYA

Dosage Form : SOLUTION

Dosage Strength : 200MG/2ML

Packaging :

Approval Date :

Application Number : 2559145

Regulatory Info : Schedule D

Registration Country : Canada

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05

AAPS
Not Confirmed
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AAPS
Not Confirmed

GUSELKUMAB

Brand Name : TREMFYA I.V.

Dosage Form : SOLUTION

Dosage Strength : 200MG/20ML

Packaging :

Approval Date :

Application Number : 2559153

Regulatory Info : Prescription

Registration Country : Canada

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06

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Solution For Injection

Dosage Strength : 100mg

Packaging :

Approval Date : 12/07/2018

Application Number : 20180731000068

Regulatory Info : Approved

Registration Country : Sweden

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07

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Solution For Injection

Dosage Strength : 100mg

Packaging :

Approval Date : 10/11/2017

Application Number : 20161125000048

Regulatory Info : Approved

Registration Country : Sweden

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08

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Solution For Injection

Dosage Strength : 200mg

Packaging :

Approval Date : 23/04/2025

Application Number : 20240502000168

Regulatory Info : Approved

Registration Country : Sweden

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09

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Solution For Injection

Dosage Strength : 200mg

Packaging :

Approval Date : 23/04/2025

Application Number : 20240502000151

Regulatory Info : Approved

Registration Country : Sweden

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10

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 200mg

Packaging :

Approval Date : 23/04/2025

Application Number : 20240502000144

Regulatory Info : Approved

Registration Country : Sweden

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11

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumabum

Brand Name : Tremfya

Dosage Form : Solution For Injection

Dosage Strength : 100mg/ml

Packaging :

Approval Date : 13/06/2018

Application Number : 66583

Regulatory Info : Allowed

Registration Country : Switzerland

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12

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumabum

Brand Name : Tremfya

Dosage Form : Solution For Injection

Dosage Strength : 200mg/2ml

Packaging :

Approval Date : 13/06/2018

Application Number : 66583

Regulatory Info : Allowed

Registration Country : Switzerland

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13

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumabum

Brand Name : Tremfya

Dosage Form : Injectable Solution

Dosage Strength : 100mg/ml

Packaging :

Approval Date : 20/12/2019

Application Number : 67490

Regulatory Info : Allowed

Registration Country : Switzerland

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14

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumabum

Brand Name : Tremfya

Dosage Form : Injectable Solution

Dosage Strength : 200mg/2ml

Packaging :

Approval Date : 20/12/2019

Application Number : 67490

Regulatory Info : Allowed

Registration Country : Switzerland

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15

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumabum

Brand Name : Tremfya

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 200mg/20ml

Packaging :

Approval Date : 10/06/2025

Application Number : 69974

Regulatory Info : Allowed

Registration Country : Switzerland

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16

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 100MG

Packaging :

Approval Date : 2017-12-14

Application Number : 1171234001

Regulatory Info : Authorized

Registration Country : Spain

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17

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : Injectable Solution In Pre-Filled Pen

Dosage Strength : 100MG

Packaging :

Approval Date : 2018-09-13

Application Number : 1171234002

Regulatory Info : Authorized

Registration Country : Spain

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18

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : PFP

Dosage Strength : 100mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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19

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form : PFS

Dosage Strength : 100mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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20

AAPS
Not Confirmed
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AAPS
Not Confirmed

Guselkumab

Brand Name : Tremfya

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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