01 17F. Hoffmann-La Roche
02 3Genentech
03 8Roche Diagnostics GmbH
01 3Concentrate For Infusion Solution
02 3Concentrate For Solution For Infusion
03 1INF
04 2INJECTABLE;SUBCUTANEOUS
05 2Injectable Solution
06 4Injection Solution
07 2SOL
08 4SOLUTION
09 2Solution For Injection
10 1VIAL; SINGLE-USE
11 4Blank
01 3Allowed
02 3Approved
03 8Authorized
04 3Originator
05 2Prescription
06 2Schedule D
07 7Blank
01 2PERJETA
02 1PERJETA-HERCEPTIN
03 4PHESGO
04 10Perjeta
05 1Perjette
06 6Phesgo
07 1Phesgo FDC 1200
08 1Phesgo FDC 600
09 2Phesgo mg
01 4Australia
02 4Canada
03 3South Africa
04 8Spain
05 3Sweden
06 3Switzerland
07 3USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Phesgo
Dosage Form : Injectable Solution
Dosage Strength : 1200mg;600mg
Packaging :
Approval Date : 21/12/2020
Application Number : 20200111000010
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Perjette
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 420mg
Packaging :
Approval Date : 04/03/2013
Application Number : 20111229000055
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Perjeta
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 420mg/14ml
Packaging :
Approval Date : 13/08/2012
Application Number : 62510
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Phesgo mg
Dosage Form : Solution For Injection
Dosage Strength : 600mg/10ml;600mg/10ml
Packaging :
Approval Date : 08/04/2021
Application Number : 67828
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Phesgo mg
Dosage Form : Solution For Injection
Dosage Strength : 1200mg/15ml;600mg/15ml
Packaging :
Approval Date : 08/04/2021
Application Number : 67828
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Phesgo
Dosage Form : Injectable Solution
Dosage Strength : 600mg/ml;600mg/ml
Packaging :
Approval Date : 21/12/2020
Application Number : 20200111000027
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PERJETA
Dosage Form : SOLUTION
Dosage Strength : 420MG/14ML
Packaging : 14ML
Approval Date :
Application Number : 2405016
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : PERJETA-HERCEPTIN
Dosage Form : SOLUTION
Dosage Strength : 420MG/14ML
Packaging : 14ML & 20ML
Approval Date :
Application Number : 2405024
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : PHESGO
Dosage Form : SOLUTION
Dosage Strength : 80MG/ML
Packaging :
Approval Date :
Application Number : 2512912
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : PHESGO
Dosage Form : SOLUTION
Dosage Strength : 60MG/ML
Packaging :
Approval Date :
Application Number : 2512920
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Phesgo FDC 1200
Dosage Form : SOL
Dosage Strength : 1200mg
Packaging : 15X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Phesgo FDC 600
Dosage Form : SOL
Dosage Strength : 600mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Perjeta
Dosage Form : INF
Dosage Strength : 420mg
Packaging : 14X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Perjeta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Perjeta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Perjeta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Perjeta
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : USA
Brand Name : PERJETA
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 420MG/14ML
Packaging :
Approval Date :
Application Number : 125409
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF
Brand Name : PHESGO
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 1,200MG;600MG;30,000UNITS
Packaging :
Approval Date :
Application Number : 761170
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF
Brand Name : PHESGO
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 600MG;600MG;20,000UNITS
Packaging :
Approval Date :
Application Number : 761170
Regulatory Info :
Registration Country : USA
