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01 3Celltrion Healthcare Hungary Kft
02 5Celltrion Healthcare Hungary Kft.
03 2Janssen Biologics Bv
04 2Pfizer Europe Ma Eeig
05 1Samsung Bioepis Nl B.V.
06 1Samsung Bioepis Nl Bv
07 2Sandoz Gmbh
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01 16Infliximab
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01 1Injectable Solution In Pre-Filled Pen
02 1Injectable Solution In Pre-Filled Syringe
03 7Powder For Concentrate For Infusion Solution
04 5Powder For Concentrate For Solution For Infusion
05 2Solution For Injection
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01 9Spain
02 7Sweden
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01 2Flixabi
02 2Inflectra
03 2Remicade
04 8Remsima
05 2Zessly
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Authorized
Registration Country : Spain
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
Regulatory Info : Cancelled
Registration Country : Spain
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Authorized
Registration Country : Spain
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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