01 6Centocor
02 11Janssen-Cilag
03 43Johnson & Johnson Innovative Medicine
01 4Concentrate For Infusion Solution
02 3Concentrate For Solution For Infusion
03 2INF
04 1INJ
05 3INJECTABLE;INJECTION
06 3Injectable Solution
07 3SOLUTION
08 1Solution For Injection
09 40Blank
01 3Allowed
02 2Approved
03 6Authorized
04 3Originator
05 2Prescription
06 1Schedule D
07 43Blank
01 6DARZALEX
02 1DARZALEX FASPRO
03 2DARZALEX SC
04 34Darzalex
05 1Darzalex 1 800mg Solution for Injection
06 16Darzalex SC
01 40Australia
02 3Canada
03 3South Africa
04 6Spain
05 2Sweden
06 3Switzerland
07 3USA
Regulatory Info :
Registration Country : USA
Brand Name : DARZALEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 100MG/5ML
Packaging :
Approval Date :
Application Number : 761036
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : DARZALEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 400MG/20ML
Packaging :
Approval Date :
Application Number : 761036
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
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
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : DARZALEX
Dosage Form : SOLUTION
Dosage Strength : 100MG/5ML
Packaging : 5ML
Approval Date :
Application Number : 2455951
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : DARZALEX
Dosage Form : SOLUTION
Dosage Strength : 400MG/20ML
Packaging : 20ML
Approval Date :
Application Number : 2455978
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : DARZALEX SC
Dosage Form : SOLUTION
Dosage Strength : 1800MG/15ML
Packaging :
Approval Date :
Application Number : 2502712
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Darzalex
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 20MG
Packaging :
Approval Date : 2019-09-24
Application Number : 1161101002IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Darzalex
Dosage Form : Injectable Solution
Dosage Strength : 1800MG
Packaging :
Approval Date : 2020-06-15
Application Number : 1161101004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Darzalex
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 20MG
Packaging :
Approval Date : 2021-01-08
Application Number : 1161101001IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Darzalex
Dosage Form : Injectable Solution
Dosage Strength : 1800MG
Packaging :
Approval Date : 2021-02-09
Application Number : 1161101004IP
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Darzalex
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 20MG
Packaging :
Approval Date : 2016-06-23
Application Number : 1161101002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Darzalex
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 20MG
Packaging :
Approval Date : 2016-06-23
Application Number : 1161101001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Darzalex 1 800mg Solution for Injection
Dosage Form : INJ
Dosage Strength : 1800mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : DARZALEX
Dosage Form : INF
Dosage Strength : 20mg
Packaging : 20X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : DARZALEX
Dosage Form : INF
Dosage Strength : 20mg
Packaging : 5X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
