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01 1Adcock Ingram

02 2Amgen Inc

03 1Aprogen

04 2CELLTRION INC.

05 52Celltrion

06 2Centocor

07 1Cipla Medpro South Africa

08 38Johnson & Johnson Innovative Medicine

09 54Organon

10 54Pfizer Consumer Healthcare

11 4Pfizer Inc

12 4Samsung Bioepis

13 2Sandoz B2B

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PharmaCompass

01

AAPS
Not Confirmed
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AAPS
Not Confirmed

INFLIXIMAB-AXXQ

Brand Name : AVSOLA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/VIAL

Packaging :

Approval Date :

Application Number : 761086

Regulatory Info :

Registration Country : USA

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02

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name :

Dosage Form :

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : South Korea

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03

AAPS
Not Confirmed
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AAPS
Not Confirmed

INFLIXIMAB-DYYB

Brand Name : INFLECTRA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 125544

Regulatory Info :

Registration Country : USA

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04

AAPS
Not Confirmed
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AAPS
Not Confirmed

INFLIXIMAB-DYYB

Brand Name : ZYMFENTRA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 120MG/ML

Packaging :

Approval Date :

Application Number : 761358

Regulatory Info :

Registration Country : USA

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05

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date : 26/08/2013

Application Number : 20120407000015

Regulatory Info : Approved

Registration Country : Sweden

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06

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Solution For Injection

Dosage Strength : 120mg

Packaging :

Approval Date : 22/11/2019

Application Number : 20181114000033

Regulatory Info : Approved

Registration Country : Sweden

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07

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Solution For Injection

Dosage Strength : 120mg

Packaging :

Approval Date : 22/11/2019

Application Number : 20181114000026

Regulatory Info : Approved

Registration Country : Sweden

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08

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Injectable Solution In Pre-Filled Pen

Dosage Strength : 120MG

Packaging :

Approval Date : 2020-02-14

Application Number : 1130853012

Regulatory Info : Authorized

Registration Country : Spain

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09

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 2015-03-24

Application Number : 13853001IP

Regulatory Info : Cancelled

Registration Country : Spain

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10

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 2014-06-23

Application Number : 13853001

Regulatory Info : Authorized

Registration Country : Spain

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11

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remsima

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 2021-02-09

Application Number : 13853001IP1

Regulatory Info : Authorized

Registration Country : Spain

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12

AAPS
Not Confirmed
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AAPS
Not Confirmed

INFLIXIMAB

Brand Name : REMICADE

Dosage Form : VIAL

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 103772

Regulatory Info :

Registration Country : USA

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13

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Remicade

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date : 13/08/1999

Application Number : 19990813000046

Regulatory Info : Approved

Registration Country : Sweden

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14

AAPS
Not Confirmed
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AAPS
Not Confirmed

INFLIXIMAB-QBTX

Brand Name : IXIFI

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/VIAL

Packaging :

Approval Date :

Application Number : 761072

Regulatory Info :

Registration Country : USA

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15

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Inflectra

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date : 10/09/2013

Application Number : 20120825000017

Regulatory Info : Approved

Registration Country : Sweden

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16

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Inflectra

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 2014-03-25

Application Number : 113854001

Regulatory Info : Authorized

Registration Country : Spain

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17

AAPS
Not Confirmed
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AAPS
Not Confirmed

INFLIXIMAB-ABDA

Brand Name : RENFLEXIS

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 761054

Regulatory Info :

Registration Country : USA

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18

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Flixabi

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date : 26/05/2016

Application Number : 20150305000183

Regulatory Info : Approved

Registration Country : Sweden

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19

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Zessly

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date : 18/05/2018

Application Number : 20170425000016

Regulatory Info : Approved

Registration Country : Sweden

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20

AAPS
Not Confirmed
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AAPS
Not Confirmed

Infliximab

Brand Name : Zessly

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 2018-07-16

Application Number : 1181280001

Regulatory Info : Authorized

Registration Country : Spain

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