01 16F. Hoffmann-La Roche
02 6Roche Diagnostics GmbH
01 2INF
02 2POWDER FOR SOLUTION
03 6Powder For Concentrate For Infusion Solution
04 4Powder For Concentrate For Solution For Infusion
05 8Blank
01 2Allowed
02 2Approved
03 6Authorized
04 2Originator
05 1Prescription
06 1Schedule D
07 8Blank
01 2KADCYLA
02 18Kadcyla
03 1Kadcyla 100
04 1Kadcyla 160
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 : Schedule D
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 : Schedule D
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
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 :
Application Number :
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 :
Application Number :
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 :
Application Number :
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
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Kadcyla
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 160MG
Packaging :
Approval Date : 2013-12-26
Application Number : 113885002
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 : 2020-11-03
Application Number : 113885001IP
Regulatory Info : Authorized
Registration Country : Spain
