01 3Celltrion Healthcare Hungary Kft
02 11Celltrion Healthcare Hungary Kft.
03 2Janssen Biologics BV
04 2Janssen Biologics Bv
05 1Orifarm AS
06 2Pfizer Europe MA EEIG (1)
07 2Pfizer Europe Ma Eeig
08 2Samsung Bioepis NL BV
09 1Samsung Bioepis Nl B.V.
10 1Samsung Bioepis Nl Bv
11 2Sandoz GmbH
12 2Sandoz Gmbh
01 31Infliximab
01 1Injectable Solution In Pre-Filled Pen
02 1Injectable Solution In Pre-Filled Syringe
03 7Powder For Concentrate For Infusion Solution
04 17Powder For Concentrate For Solution For Infusion
05 3Solution For Injection
06 2Solution For Injection In Pre-Filled Pen
01 3Moldova
02 12Norway
03 9Spain
04 7Sweden
01 4Flixabi
02 4Inflectra
03 5Remicade
04 11Remsima
05 1Remsima® 100 mg
06 2Remsima® 120 mg
07 4Zessly
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
