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01 22F. Hoffmann-La Roche

02 6Roche Diagnostics GmbH

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PharmaCompass

01

BioProcess International
Not Confirmed
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BioProcess International
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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02

BioProcess International
Not Confirmed
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BioProcess International
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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03

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumabemtansin

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumabemtansin

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 160mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 160mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

BioProcess International
Not Confirmed
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BioProcess International
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 : 28105143712

Regulatory Info : Prescription

Registration Country : Denmark

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08

BioProcess International
Not Confirmed
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BioProcess International
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 : 28105143812

Regulatory Info : Prescription

Registration Country : Denmark

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09

BioProcess International
Not Confirmed
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BioProcess International
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 : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

BioProcess International
Not Confirmed
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BioProcess International
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 : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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11

BioProcess International
Not Confirmed
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BioProcess International
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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12

BioProcess International
Not Confirmed
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BioProcess International
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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13

BioProcess International
Not Confirmed
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BioProcess International
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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14

BioProcess International
Not Confirmed
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BioProcess International
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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15

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 26-12-2013

Application Number : 113885001

Regulatory Info : Authorized

Registration Country : Spain

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16

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 160MG

Packaging :

Approval Date : 03-11-2020

Application Number : 113885002IP

Regulatory Info : Authorized

Registration Country : Spain

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17

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 22-05-2024

Application Number : 113885001IP1

Regulatory Info : Authorized

Registration Country : Spain

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18

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 160MG

Packaging :

Approval Date : 22-05-2024

Application Number : 113885002IP1

Regulatory Info : Authorized

Registration Country : Spain

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19

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 160MG

Packaging :

Approval Date : 26-12-2013

Application Number : 113885002

Regulatory Info : Authorized

Registration Country : Spain

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20

BioProcess International
Not Confirmed
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BioProcess International
Not Confirmed

Trastuzumab Emtansine

Brand Name : Kadcyla

Dosage Form : Powder For Concentrate For Infusion Solution

Dosage Strength : 100MG

Packaging :

Approval Date : 03-11-2020

Application Number : 113885001IP

Regulatory Info : Authorized

Registration Country : Spain

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