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01 17Alexion Pharmaceuticals
02 3Amgen Inc
03 3Samsung Bioepis
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01 3Concentrate For Infusion Solution
02 4Concentrate For Solution For Infusion
03 1INJECTABLE; IV (INFUSION)
04 1INJECTABLE;INJECTION
05 1INJECTION;SOLUTION
06 1SOLUTION
07 12Blank
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01 1Allowed
02 3Approved
03 3Authorized
04 1Prescription
05 15Blank
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01 1BKEMV
02 2Bekemv
03 1EPYSQLI
04 2Epysqli
05 2SOLIRIS
06 15Soliris
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01 12Australia
02 1Canada
03 3Spain
04 3Sweden
05 1Switzerland
06 3USA
Regulatory Info :
Registration Country : USA
Brand Name : SOLIRIS
Dosage Form : INJECTABLE; IV (INFUSION)
Dosage Strength : 300MG
Packaging :
Approval Date :
Application Number : 125166
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Soliris
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 10mg/ml
Packaging :
Approval Date : 20/06/2007
Application Number : 20061202000018
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Soliris
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 300mg/30ml
Packaging :
Approval Date : 04/01/2010
Application Number : 59282
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SOLIRIS
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 30ML
Approval Date :
Application Number : 2322285
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Soliris
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : USA
Brand Name : BKEMV
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 300MG/30ML(10MG/ML)
Packaging :
Approval Date :
Application Number : 761333
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Bekemv
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 300mg
Packaging :
Approval Date : 19/04/2023
Application Number : 20220304000061
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : USA
Brand Name : EPYSQLI
Dosage Form : INJECTION;SOLUTION
Dosage Strength : 300 mg/30 mL (10 mg/mL)
Packaging :
Approval Date :
Application Number : 761340
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Epysqli
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 300mg
Packaging :
Approval Date : 26/05/2023
Application Number : 20220623000025
Regulatory Info : Approved
Registration Country : Sweden