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01 14Amgen Inc

02 2Celltrion

03 4Fresenius Kabi USA

04 4Samsung Bioepis

05 4Sandoz B2B

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PharmaCompass

01

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB

Brand Name : PROLIA

Dosage Form : INJECTABLE; SUBCUTANEOUS

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 125320

Regulatory Info :

Registration Country : USA

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02

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB

Brand Name : XGEVA

Dosage Form : INJECTABLE; SUBCUTANEOUS

Dosage Strength : 70MG/ML

Packaging :

Approval Date :

Application Number : 125320

Regulatory Info :

Registration Country : USA

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03

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

denosumab

Brand Name : Prolia

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 60 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

denosumab

Brand Name : Prolia

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 60 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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05

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

denosumab

Brand Name : XGEVA

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 120 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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06

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

Denosumab

Brand Name : Xgeva

Dosage Form : Solution for injection, solution in pre-filled syringe

Dosage Strength : 120 mg

Packaging : Pre-filled syringe 1ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

Denosumabum

Brand Name : Prolia

Dosage Form : Inj L?s

Dosage Strength : 60mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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08

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

Denosumabum

Brand Name : Xgeva

Dosage Form : Inj Soluble

Dosage Strength : 120mg/1.7ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BMWO

Brand Name : STOBOCLO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 761404

Regulatory Info :

Registration Country : USA

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10

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BMWO

Brand Name : OSENVELT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 120MG/1.7ML(70MG/ML)

Packaging :

Approval Date :

Application Number : 761404

Regulatory Info :

Registration Country : USA

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11

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BNHT

Brand Name : BOMYNTRA

Dosage Form : INJECTION

Dosage Strength : 120MG/1.7ML (70 MG/ML)

Packaging :

Approval Date :

Application Number : 761398

Regulatory Info :

Registration Country : USA

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12

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BNHT

Brand Name : CONEXXENCE

Dosage Form : INJECTION

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 761398

Regulatory Info :

Registration Country : USA

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13

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BNHT

Brand Name : DENOSUMAB-BNHT

Dosage Form : INJECTION

Dosage Strength : 120MG/1.7ML (70 MG/ML)

Packaging :

Approval Date :

Application Number : 761398

Regulatory Info :

Registration Country : USA

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14

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BNHT

Brand Name : DENOSUMAB-BNHT

Dosage Form : INJECTION

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 761398

Regulatory Info :

Registration Country : USA

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15

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-DSSB

Brand Name : OSPOMYV

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 761392

Regulatory Info :

Registration Country : USA

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16

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-DSSB

Brand Name : XBRYK

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 70MG/ML

Packaging :

Approval Date :

Application Number : 761392

Regulatory Info :

Registration Country : USA

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17

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-DSSB

Brand Name : DENOSUMAB-DSSB

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 761392

Regulatory Info :

Registration Country : USA

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18

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-DSSB

Brand Name : DENOSUMAB-DSSB

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 70MG/ML

Packaging :

Approval Date :

Application Number : 761392

Regulatory Info :

Registration Country : USA

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19

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BBDZ

Brand Name : JUBBONTI

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 60MG/ML

Packaging :

Approval Date :

Application Number : 761362

Regulatory Info :

Registration Country : USA

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20

IMCAS Asia
Not Confirmed
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IMCAS Asia
Not Confirmed

DENOSUMAB-BBDZ

Brand Name : WYOST

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 120MG/1.7ML (70MG/ML)

Packaging :

Approval Date :

Application Number : 761362

Regulatory Info :

Registration Country : USA

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