01 1Accord BioPharma
02 15Accord healthcare
03 15Amgen Inc
04 1Aprogen
05 16Arrotex Pharmaceuticals
06 2Aryogen Pharmed
07 6AstraZeneca
08 2BIOSIMILAR COLLABORATIONS IRELAND LIMITED
09 2Biocon
10 10Biosimilar Collaborations Ireland Limited
11 46Celltrion
12 2CinnaGen
13 1Cipla Medpro South Africa
14 1Clinigen Group
15 3CuraTeQ Biologics
16 5Daiichi Sankyo
17 49F. Hoffmann-La Roche
18 3Genentech
19 1Imperial Market Access Healthcare SA (Pty) Ltd
20 2Iqone Healthcare Switzerland Sa
21 2Medius Ag
22 32Pfizer Consumer Healthcare
23 15Pfizer Inc
24 6Prestige BioPharma Pte Ltd
25 8Roche Diagnostics GmbH
26 12Samsung Bioepis
27 19Sandoz B2B
28 1Viatris
01 5INJ
02 4INJECTABLE;INJECTION
03 2INJECTABLE;SUBCUTANEOUS
04 2Infusion Concentrate
05 2Injectable
06 9Injectable Solution
07 3Injectable Solution In Vial
08 7Injection Solution
09 2KIT
10 1POI
11 11POWDER FOR SOLUTION
12 2POWDER;IV (INFUSION)
13 2Powder And Solvent For Concentrate For Solution For Infusion
14 17Powder For Concentrate For Infusion Solution
15 77Powder For Concentrate For Solution For Infusion
16 2SOL
17 3SOLUTION
18 14Solution For Injection
19 1Subcutaneous Injectable Solution
20 1Trastuzumab 150Mg 1 Unit Parenteral Use
21 1Trastuzumab 600Mg 1 Unit Parenteral Use
22 1VIAL; INTRAVENOUS
23 1VIAL; MULTIDOSE
24 1VIAL;SINGLE-DOSE
25 6injection
26 101Blank
01 17Allowed
02 22Approved
03 26Authorized
04 1Deregistered
05 3Generic
06 7Marketed
07 5Not Marketed
08 5Originator
09 51Prescription
10 7Schedule D
11 134Blank
01 1 Kadcyla 100 mg powder for concentrate for solution for infusion
02 1 Kadcyla 160 mg powder for concentrate for solution for infusion
03 4AryoTrust
04 2Canhera
05 3Dazublys
06 1ENHERTU
07 10Enhertu
08 1Equituz
09 2HERCEPTIN
10 1HERCEPTIN SC
11 1HERCESSI
12 3HERZUMA
13 17Herceptin
14 1Herceptin 21 mg/ml IV
15 6Herceptin SC
16 1Herceptin SC 600mg
17 1Herceptin subcutaneous
18 2Herceptin®
19 2Herclon
20 2Herewenda
21 1Herwenda
22 44Herzuma
23 1Herzuma® 150 mg
24 4KANJINTI
25 27Kanjinti
26 3OGIVRI
27 1OGIVRI 21mg/ml IV
28 4ONTRUZANT
29 28Ogivri
30 8Ontruzant
31 1PERJETA-HERCEPTIN
32 4PHESGO
33 14Phesgo
34 1Phesgo FDC 1200
35 1Phesgo FDC 600
36 2Phesgo mg
37 2Phesgo®
38 3TRAZIMERA
39 1Trastuzumab Cipla 440 mg
40 44Trazimera
41 6Tuznue
42 14Zercepac
43 1Zercepac®
44 1Blank
01 106Australia
02 16Canada
03 21Denmark
04 21Estonia
05 2Iran
06 2Italy
07 12Moldova
08 12Norway
09 8South Africa
10 1South Korea
11 26Spain
12 23Sweden
13 17Switzerland
14 11USA
Regulatory Info :
Registration Country : USA
Brand Name : KANJINTI
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 420MG
Packaging :
Approval Date :
Application Number : 761073
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : KANJINTI
Dosage Form : VIAL;SINGLE-DOSE
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 761073
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kanjinti
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 150mg
Packaging :
Approval Date : 16-05-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Kanjinti
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 420mg
Packaging :
Approval Date : 16-05-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : USA
Brand Name : HERZUMA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 420MG
Packaging :
Approval Date :
Application Number : 761091
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Herzuma
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 150mg
Packaging :
Approval Date : 09-02-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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 : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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 : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Herceptin
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 150mg
Packaging :
Approval Date : 28-08-2000
Application Number : 2.00E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Herceptin
Dosage Form : Injectable Solution
Dosage Strength : 600mg/5ml
Packaging :
Approval Date : 26-08-2013
Application Number : 2.01E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Herceptin
Dosage Form : Injectable Solution
Dosage Strength : 600mg/5ml
Packaging :
Approval Date : 24-07-2014
Application Number : 2.01E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info :
Registration Country : USA
Brand Name : HERCEPTIN
Dosage Form : VIAL; INTRAVENOUS
Dosage Strength : 21MG/ML
Packaging :
Approval Date :
Application Number : 103792
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
Regulatory Info :
Registration Country : USA
Brand Name : TRAZIMERA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 420MG
Packaging :
Approval Date :
Application Number : 761081
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Trazimera
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 150mg
Packaging :
Approval Date : 26-07-2018
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : USA
Brand Name : ONTRUZANT
Dosage Form : POWDER;IV (INFUSION)
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 761100
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : ONTRUZANT
Dosage Form : POWDER;IV (INFUSION)
Dosage Strength : 420MG
Packaging :
Approval Date :
Application Number : 761100
Regulatory Info :
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ontruzant
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 150mg
Packaging :
Approval Date : 15-11-2017
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info :
Registration Country : USA
Brand Name : OGIVRI
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 420MG/VIAL
Packaging :
Approval Date :
Application Number : 761074
Regulatory Info :
Registration Country : USA
