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01 2Abacus Medicine

02 6Centocor

03 26Janssen-Cilag

04 43Johnson & Johnson Innovative Medicine

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PharmaCompass

01

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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02

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

DARATUMUMAB

Brand Name : DARZALEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/5ML

Packaging :

Approval Date :

Application Number : 761036

Regulatory Info :

Registration Country : USA

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04

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

DARATUMUMAB

Brand Name : DARZALEX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 400MG/20ML

Packaging :

Approval Date :

Application Number : 761036

Regulatory Info :

Registration Country : USA

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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

DARATUMUMAB AND HYALURONIDASE-FIHJ

Brand Name : DARZALEX FASPRO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 120MG;2000UNITS/ML

Packaging :

Approval Date :

Application Number : 761145

Regulatory Info :

Registration Country : USA

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Injectable Solution

Dosage Strength : 1800mg

Packaging :

Approval Date : 03/06/2020

Application Number : 20190724000043

Regulatory Info : Approved

Registration Country : Sweden

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 20/05/2016

Application Number : 20150911000058

Regulatory Info : Approved

Registration Country : Sweden

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08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumabum

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mg/5ml

Packaging :

Approval Date : 06/12/2016

Application Number : 66072

Regulatory Info : Allowed

Registration Country : Switzerland

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09

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumabum

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 400mg/20ml

Packaging :

Approval Date : 06/12/2016

Application Number : 66072

Regulatory Info : Allowed

Registration Country : Switzerland

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10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumabum

Brand Name : DARZALEX SC

Dosage Form : Solution For Injection

Dosage Strength : 1800mg/15ml

Packaging :

Approval Date : 13/08/2020

Application Number : 67689

Regulatory Info : Allowed

Registration Country : Switzerland

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11

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex®

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 19-11-2020

Application Number :

Regulatory Info :

Registration Country : Moldova

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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex®

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date : 19-11-2020

Application Number :

Regulatory Info :

Registration Country : Moldova

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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex®

Dosage Form : Injectable Solution

Dosage Strength :

Packaging :

Approval Date : 03-02-2025

Application Number :

Regulatory Info :

Registration Country : Moldova

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Solution For Injection

Dosage Strength : 1800mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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15

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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16

ASPEN
Not Confirmed
arrow
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Solution For Injection

Dosage Strength : 1800mg/15ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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18

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml; 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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19

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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20

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Daratumumab

Brand Name : Darzalex

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 20MG

Packaging :

Approval Date : 24-09-2019

Application Number : 1161101002IP

Regulatory Info : Authorized

Registration Country : Spain

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