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01 103Bristol Myers Squibb

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PharmaCompass

01

AAPS
Not Confirmed
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AAPS
Not Confirmed

NIVOLUMAB

Brand Name : OPDIVO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/4ML

Packaging :

Approval Date :

Application Number : 125527

Regulatory Info :

Registration Country : USA

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02

AAPS
Not Confirmed
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AAPS
Not Confirmed

NIVOLUMAB

Brand Name : OPDIVO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 100MG/10ML

Packaging :

Approval Date :

Application Number : 125527

Regulatory Info :

Registration Country : USA

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03

AAPS
Not Confirmed
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AAPS
Not Confirmed

NIVOLUMAB

Brand Name : OPDIVO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/4ML

Packaging :

Approval Date :

Application Number : 125554

Regulatory Info :

Registration Country : USA

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04

AAPS
Not Confirmed
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AAPS
Not Confirmed

NIVOLUMAB;RELATLIMAB-RMBW

Brand Name : OPDUALAG

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 240MG;80MG

Packaging :

Approval Date :

Application Number : 761234

Regulatory Info :

Registration Country : USA

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05

AAPS
Not Confirmed
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AAPS
Not Confirmed

NIVOLUMAB;HYALURONIDASE-NVHY

Brand Name : OPDIVO QVANTIG

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML)

Packaging :

Approval Date :

Application Number : 761381

Regulatory Info :

Registration Country : USA

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06

AAPS
Not Confirmed
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AAPS
Not Confirmed

NIVOLUMAB;HYALURONIDASE-NVHY

Brand Name : OPDIVO QVANTIG

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER ML)

Packaging :

Approval Date :

Application Number : 761429

Regulatory Info :

Registration Country : USA

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07

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab; Relatlimab (Combination drug known as Opdualag)

Brand Name : Opdualag

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 240mg;80mg

Packaging :

Approval Date : 15/09/2022

Application Number : 20210913000057

Regulatory Info : Approved

Registration Country : Sweden

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08

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 10mg/ml

Packaging :

Approval Date : 19/06/2015

Application Number : 20141009000029

Regulatory Info : Approved

Registration Country : Sweden

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09

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Injectable Solution

Dosage Strength : 600mg

Packaging :

Approval Date : 26/05/2025

Application Number : 20240607000049

Regulatory Info : Approved

Registration Country : Sweden

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10

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Nivolumab Bms

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 10mg/ml

Packaging :

Approval Date : 20/07/2015

Application Number : 20141009000036

Regulatory Info : Deregistered

Registration Country : Sweden

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11

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 40mg/4ml

Packaging :

Approval Date : 30/11/2015

Application Number : 65660

Regulatory Info : Allowed

Registration Country : Switzerland

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12

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 100mg/10ml

Packaging :

Approval Date : 30/11/2015

Application Number : 65660

Regulatory Info : Allowed

Registration Country : Switzerland

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13

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 240mg/24ml

Packaging :

Approval Date : 30/11/2015

Application Number : 65660

Regulatory Info : Allowed

Registration Country : Switzerland

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14

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 120mg/12ml

Packaging :

Approval Date : 30/11/2015

Application Number : 65660

Regulatory Info : Allowed

Registration Country : Switzerland

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15

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2021-07-01

Application Number : 1151014001IP1

Regulatory Info : Authorized

Registration Country : Spain

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16

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2019-11-12

Application Number : 1151014002IP

Regulatory Info : Authorized

Registration Country : Spain

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17

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2015-07-06

Application Number : 1151014001

Regulatory Info : Authorized

Registration Country : Spain

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18

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2020-03-04

Application Number : 1151014001IP

Regulatory Info : Authorized

Registration Country : Spain

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19

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2021-07-01

Application Number : 1151014002IP1

Regulatory Info : Authorized

Registration Country : Spain

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20

AAPS
Not Confirmed
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AAPS
Not Confirmed

Nivolumab

Brand Name : Opdivo

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 10MG

Packaging :

Approval Date : 2015-07-06

Application Number : 1151014002

Regulatory Info : Authorized

Registration Country : Spain

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