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01 16F. Hoffmann-La Roche

02 6Roche Diagnostics GmbH

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PharmaCompass

01

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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02

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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03

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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04

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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05

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

TRASTUZUMAB EMTANSINE

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

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06

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

TRASTUZUMAB EMTANSINE

Brand Name : KADCYLA

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 160MG/VIAL

Packaging :

Approval Date :

Application Number : 2473224

Regulatory Info : Prescription

Registration Country : Canada

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07

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla 100

Dosage Form : INF

Dosage Strength : 100mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla 160

Dosage Form : INF

Dosage Strength : 160mg

Packaging : 8X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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11

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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12

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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13

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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14

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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15

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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18

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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19

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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20

Aus. Peptide Conference
Not Confirmed
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Aus. Peptide Conference
Not Confirmed

Trastuzumab Emtansine

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

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