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01 18GSK

02 4Janssen-Cilag

03 2Johnson & Johnson Innovative Medicine

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PharmaCompass

01

The MedTech Conference
Not Confirmed
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The MedTech Conference
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NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2017-03-27

Application Number : 208447

Regulatory Info : DISCN

Registration Country : USA

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02

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2023-04-26

Application Number : 214876

Regulatory Info : RX

Registration Country : USA

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03

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 200MG BASE

Packaging :

Approval Date : 2023-04-26

Application Number : 214876

Regulatory Info : RX

Registration Country : USA

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04

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Packaging :

Approval Date : 2023-04-26

Application Number : 214876

Regulatory Info : RX

Registration Country : USA

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05

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Packaging : Blisterpakning 56item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Packaging : Blisterpakning 84item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparibum

Brand Name : Zejula capsules

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 03/10/2018

Application Number : 66763

Regulatory Info : Allowed

Registration Country : Switzerland

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08

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparibum

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 20/01/2023

Application Number : 68652

Regulatory Info : Allowed

Registration Country : Switzerland

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09

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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10

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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11

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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12

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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13

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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14

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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15

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib; Abiraterone Acetate

Brand Name : Akeega mg

Dosage Form : Film Coated Tablet

Dosage Strength : 50mg;500mg

Packaging :

Approval Date : 18/04/2024

Application Number : 68977

Regulatory Info : Allowed

Registration Country : Switzerland

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18

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib; Abiraterone Acetate

Brand Name : Akeega mg

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;500mg

Packaging :

Approval Date : 18/04/2024

Application Number : 68977

Regulatory Info : Allowed

Registration Country : Switzerland

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19

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : AKEEGA 50 mg /500 mg

Dosage Form : FCT

Dosage Strength : 50mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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20

The MedTech Conference
Not Confirmed
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The MedTech Conference
Not Confirmed

Niraparib

Brand Name : AKEEGA 100 mg /500 mg

Dosage Form : FCT

Dosage Strength : 100mg

Packaging : 56X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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