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01 3Accord BioPharma
02 12Accord healthcare
03 2Alvotech
04 21Amgen Inc
05 2Bio-Thera Solutions
06 2Biocon Biologics
07 7Biosimilar Collaborations Ireland Limited
08 3CELLTRION INC.
09 44Celltrion
10 9Centocor
11 3Formycon
12 6Fresenius Kabi AB Brunna
13 3Fresenius Kabi Austria
14 3Iqone Healthcare Switzerland Sa
15 2JAMP PHARMA
16 22Janssen-Cilag
17 21Johnson & Johnson Innovative Medicine
18 8STADA Arzneimittel
19 19Samsung Bioepis
20 2Spirig Healthcare
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01 9Concentrate For Infusion Solution
02 14Concentrate For Solution For Infusion
03 1INJ
04 2INJECTABLE; INJECTION
05 7INJECTABLE;INJECTION
06 4INJECTABLE;INTRAVENOUS
07 3INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
08 5INJECTABLE;SUBCUTANEOUS
09 8Injectable Solution
10 6Injectable Solution In Pre-Filled Pen
11 18Injectable Solution In Pre-Filled Syringe
12 2PFS
13 20SOLUTION
14 40Solution For Injection
15 2Solution for injection, solution in pre-filled syringe
16 2Ustekinumab 45Mg 0,5Ml 1 Unit Parenteral Use
17 1Ustekinumab 90Mg 1Ml 1 Units Parenteral Use
18 50Blank
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01 14Allowed
02 45Approved
03 35Authorized
04 1Deregistered
05 3Originator
06 10Prescription
07 10Schedule D
08 76Blank
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01 6Absimky
02 3Eksunbi
03 2FINLIUS
04 1FINLIUS I.V.
05 3Fymskipa
06 3IMULDOSA
07 6Imuldosa
08 2JAMTEKI
09 2OTULFI
10 1OTULFI I.V.
11 6Otulfi
12 3PYZCHIVA
13 12Pyzchiva
14 1Pyzchiva
15 3Qoyvolma
16 2SELARSDI
17 2STARJEMZA
18 5STELARA
19 1STELARA I.V.
20 5STEQEYMA
21 1STEQEYMA IV
22 38Stelara
23 2Stelara
24 1Stelara 130 mg
25 1Stelara 45 Mg
26 1Stelara 90 mg
27 38Steqeyma
28 3Steqeyma
29 3Test
30 2Ustekinumab Spirig HC
31 5Uzpruvo
32 8WEZLANA
33 1WEZLANA I.V.
34 12Wezenla
35 2YESINTEK
36 7Yesintek
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01 50Australia
02 20Canada
03 3Italy
04 2Norway
05 3South Africa
06 35Spain
07 46Sweden
08 14Switzerland
09 21USA
Regulatory Info :
Registration Country : USA
Brand Name : IMULDOSA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761364
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMULDOSA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761364
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMULDOSA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761364
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SELARSDI
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761343
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SELARSDI
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761343
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : WEZLANA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761285
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : WEZLANA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761285
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : WEZLANA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761331
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STARJEMZA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761419
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STARJEMZA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761419
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : YESINTEK
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761406
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : YESINTEK
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761406
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STEQEYMA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761338
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STEQEYMA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761338
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STEQEYMA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761338
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STELARA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 125261
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STELARA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 90MG/1ML
Packaging :
Approval Date :
Application Number : 125261
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STELARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761044
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : PYZCHIVA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761373
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : PYZCHIVA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761373
Regulatory Info :
Registration Country : USA