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01 3Accord healthcare

02 22Novartis Pharmaceuticals Corporation

03 4Novartis South Africa (Pty) Ltd

04 3Spirig Healthcare

05 3Zentiva

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PharmaCompass

01

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Nilotinib Accord

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date : 23/08/2024

Application Number : 20230627000075

Regulatory Info : Approved

Registration Country : Sweden

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02

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Nilotinib Accord

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 23/08/2024

Application Number : 20230627000082

Regulatory Info : Approved

Registration Country : Sweden

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03

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Nilotinib Accord

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date : 23/08/2024

Application Number : 20230627000068

Regulatory Info : Approved

Registration Country : Sweden

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04

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2019-05-24

Application Number : 212526

Regulatory Info : RX

Registration Country : USA

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05

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG

Packaging :

Approval Date : 2019-05-24

Application Number : 212526

Regulatory Info : RX

Registration Country : USA

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06

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : PIQRAY

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2019-05-24

Application Number : 212526

Regulatory Info : RX

Registration Country : USA

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07

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : VIJOICE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Packaging :

Approval Date : 2022-04-05

Application Number : 215039

Regulatory Info : RX

Registration Country : USA

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08

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : VIJOICE

Dosage Form : TABLET;ORAL

Dosage Strength : 125MG

Packaging :

Approval Date : 2022-04-05

Application Number : 215039

Regulatory Info : RX

Registration Country : USA

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09

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : VIJOICE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2022-04-05

Application Number : 215039

Regulatory Info : RX

Registration Country : USA

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10

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

ALPELISIB

Brand Name : VIJOICE

Dosage Form : GRANULES;ORAL

Dosage Strength : 50MG/PACKET

Packaging :

Approval Date : 2024-04-24

Application Number : 218466

Regulatory Info : RX

Registration Country : USA

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11

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Alpelisib

Brand Name : Piqray

Dosage Form : Film Coated Tablet

Dosage Strength : 150mg

Packaging :

Approval Date : 24/03/2020

Application Number : 67359

Regulatory Info : Allowed

Registration Country : Switzerland

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12

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Alpelisib

Brand Name : Piqray +

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 24/03/2020

Application Number : 67359

Regulatory Info : Allowed

Registration Country : Switzerland

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13

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Alpelisib

Brand Name : Piqray

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 24/03/2020

Application Number : 67359

Regulatory Info : Allowed

Registration Country : Switzerland

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14

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Alpelisib

Brand Name : Piqray

Dosage Form : Film Coated Tablet

Dosage Strength : 150mg

Packaging :

Approval Date : 27/07/2020

Application Number : 20181220000088

Regulatory Info : Approved

Registration Country : Sweden

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15

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Alpelisib

Brand Name : Piqray

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 27/07/2020

Application Number : 20181220000095

Regulatory Info : Approved

Registration Country : Sweden

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16

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Alpelisib

Brand Name : Piqray

Dosage Form : Film Coated Tablet

Dosage Strength : 50mg;200mg

Packaging :

Approval Date : 27/07/2020

Application Number : 20181220000071

Regulatory Info : Approved

Registration Country : Sweden

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17

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Tasigna

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 24/07/2007

Application Number : 58007

Regulatory Info : Allowed

Registration Country : Switzerland

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18

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Nilotinib Zentiva

Dosage Form : Capsule

Dosage Strength : 150mg

Packaging :

Approval Date : 17/01/2025

Application Number : 20230703000135

Regulatory Info : Approved

Registration Country : Sweden

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19

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Nilotinib Zentiva

Dosage Form : Capsule

Dosage Strength : 200mg

Packaging :

Approval Date : 17/01/2025

Application Number : 20230703000142

Regulatory Info : Approved

Registration Country : Sweden

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20

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Nilotinib

Brand Name : Nilotinib Zentiva

Dosage Form : Capsule

Dosage Strength : 50mg

Packaging :

Approval Date : 17/01/2025

Application Number : 20230703000128

Regulatory Info : Approved

Registration Country : Sweden

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