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01 16F. Hoffmann-La Roche
02 6Roche Diagnostics GmbH
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01 2INF
02 2POWDER FOR SOLUTION
03 6Powder For Concentrate For Infusion Solution
04 4Powder For Concentrate For Solution For Infusion
05 8Blank
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01 2Allowed
02 2Approved
03 6Authorized
04 2Originator
05 2Prescription
06 8Blank
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01 2KADCYLA
02 18Kadcyla
03 1Kadcyla 100
04 1Kadcyla 160
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01 8Australia
02 2Canada
03 2South Africa
04 6Spain
05 2Sweden
06 2Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 100mg
Packaging :
Approval Date : 15/11/2013
Application Number : 20121010000058
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 160mg
Packaging :
Approval Date : 15/11/2013
Application Number : 20121010000065
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 100mg
Packaging :
Approval Date : 02/05/2013
Application Number : 62892
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 160mg
Packaging :
Approval Date : 02/05/2013
Application Number : 62892
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : KADCYLA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 100MG/VIAL
Packaging : 15ML/20ML
Approval Date :
Application Number : 2412365
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : KADCYLA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 160MG/VIAL
Packaging :
Approval Date :
Application Number : 2473224
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kadcyla 100
Dosage Form : INF
Dosage Strength : 100mg
Packaging : 5X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Kadcyla 160
Dosage Form : INF
Dosage Strength : 160mg
Packaging : 8X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Kadcyla
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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Regulatory Info :
Registration Country : Australia
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2013-12-26
Application Number : 113885001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 160MG
Packaging :
Approval Date : 2020-11-03
Application Number : 113885002IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2024-05-22
Application Number : 113885001IP1
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 160MG
Packaging :
Approval Date : 2024-05-22
Application Number : 113885002IP1
Regulatory Info : Authorized
Registration Country : Spain