01 16F. Hoffmann-La Roche
02 4Genentech
03 2Roche Diagnostics GmbH
01 4INJ
02 4INJECTABLE;INJECTION
03 4Injectable Solution
04 4SOLUTION
05 6Solution For Injection
01 6Allowed
02 2Approved
03 2Authorized
04 4Originator
05 1Prescription
06 3Schedule D
07 4Blank
01 8HEMLIBRA
02 5Hemlibra
03 3Hemlibra
04 1Hemlibra 105mg/0.7 ml
05 1Hemlibra 150mg/1 ml
06 1Hemlibra 30mg/1 ml
07 1Hemlibra 60mg/0.4 ml
08 2Home Libra
01 4Canada
02 4South Africa
03 2Spain
04 2Sweden
05 6Switzerland
06 4USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Home Libra
Dosage Form : Injectable Solution
Dosage Strength : 150mg/ml
Packaging :
Approval Date : 23/02/2018
Application Number : 20170626000051
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Home Libra
Dosage Form : Injectable Solution
Dosage Strength : 30mg/ml
Packaging :
Approval Date : 23/02/2018
Application Number : 20170626000044
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Solution For Injection
Dosage Strength : 30mg/ml
Packaging :
Approval Date : 06/11/2018
Application Number : 66694
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Solution For Injection
Dosage Strength : 60mg/0.4ml
Packaging :
Approval Date : 06/11/2018
Application Number : 66694
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Solution For Injection
Dosage Strength : 105mg/0.7ml
Packaging :
Approval Date : 06/11/2018
Application Number : 66694
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Solution For Injection
Dosage Strength : 150mg/ml
Packaging :
Approval Date : 06/11/2018
Application Number : 66694
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Solution For Injection
Dosage Strength : 12mg/0.4ml
Packaging :
Approval Date : 06/11/2018
Application Number : 66694
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Hemlibra
Dosage Form : Solution For Injection
Dosage Strength : 300mg/2ml
Packaging :
Approval Date : 06/11/2018
Application Number : 66694
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 30MG/1ML
Packaging : 1ML
Approval Date :
Application Number : 2479621
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 60MG/0.4ML
Packaging : 0.4ML
Approval Date :
Application Number : 2479648
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 105MG/0.7ML
Packaging : 0.7ML
Approval Date :
Application Number : 2479656
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HEMLIBRA
Dosage Form : SOLUTION
Dosage Strength : 150MG/ML
Packaging :
Approval Date :
Application Number : 2479664
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 105mg/0.7 ml
Dosage Form : INJ
Dosage Strength : 105mg
Packaging : 0.7X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 150mg/1 ml
Dosage Form : INJ
Dosage Strength : 150mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 60mg/0.4 ml
Dosage Form : INJ
Dosage Strength : 60mg
Packaging : 0.4X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Hemlibra 30mg/1 ml
Dosage Form : INJ
Dosage Strength : 30mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : USA
Brand Name : HEMLIBRA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 30MG/ML
Packaging :
Approval Date :
Application Number : 761083
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : HEMLIBRA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 60MG/0.4ML
Packaging :
Approval Date :
Application Number : 761083
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : HEMLIBRA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 105MG/0.7ML
Packaging :
Approval Date :
Application Number : 761083
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : HEMLIBRA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 761083
Regulatory Info :
Registration Country : USA
