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01 3Janssen-Cilag Ag
02 6Janssen-Cilag International N.V.
03 2Janssen-Cilag International Nv
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01 8Daratumumab
02 3Daratumumabum
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01 4Concentrate For Infusion Solution
02 3Concentrate For Solution For Infusion
03 3Injectable Solution
04 1Solution For Injection
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01 6Spain
02 2Sweden
03 3Switzerland
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01 1DARZALEX SC
02 10Darzalex
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