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01 2ARIAD PHARMA LTD

02 2Apotex Inc

03 2Incyte Biosciences UK Ltd

04 9Incyte Corporation

05 1TAKEDA PHARMACEUTICALS U.S.A., INC.

06 4Takeda Pharmaceutical

07 6Takeda Pharmaceuticals Australia Pty. Ltd.

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PharmaCompass

01

AAPS
Not Confirmed
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AAPS
Not Confirmed

PONATINIB HYDROCHLORIDE

Brand Name : PONATINIB HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Packaging :

Approval Date : 2023-07-14

Application Number : 215893

Regulatory Info : DISCN

Registration Country : USA

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02

AAPS
Not Confirmed
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AAPS
Not Confirmed

PONATINIB HYDROCHLORIDE

Brand Name : PONATINIB HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 45MG BASE

Packaging :

Approval Date : 2023-07-14

Application Number : 215893

Regulatory Info : DISCN

Registration Country : USA

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03

AAPS
Not Confirmed
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AAPS
Not Confirmed

Ponatinibhydroklorid

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 15mg

Packaging :

Approval Date : 01/07/2013

Application Number : 20120902000015

Regulatory Info : Approved

Registration Country : Sweden

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04

AAPS
Not Confirmed
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AAPS
Not Confirmed

Ponatinibhydroklorid

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 27/11/2015

Application Number : 20150506000098

Regulatory Info : Approved

Registration Country : Sweden

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05

AAPS
Not Confirmed
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AAPS
Not Confirmed

Ponatinibhydroklorid

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 45mg

Packaging :

Approval Date : 01/07/2013

Application Number : 20120902000046

Regulatory Info : Approved

Registration Country : Sweden

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06

AAPS
Not Confirmed
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AAPS
Not Confirmed

Put It Away

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 15mg

Packaging :

Approval Date : 12/02/2014

Application Number : 63097

Regulatory Info : Allowed

Registration Country : Switzerland

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07

AAPS
Not Confirmed
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AAPS
Not Confirmed

Put It Away

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 40mg

Packaging :

Approval Date : 12/02/2014

Application Number : 63097

Regulatory Info : Allowed

Registration Country : Switzerland

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08

AAPS
Not Confirmed
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AAPS
Not Confirmed

Put It Away

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 12/02/2014

Application Number : 63097

Regulatory Info : Allowed

Registration Country : Switzerland

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09

AAPS
Not Confirmed
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 45MG

Packaging :

Approval Date : 2013-09-20

Application Number : 113839003

Regulatory Info : Authorized

Registration Country : Spain

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10

AAPS
Not Confirmed
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 15MG

Packaging :

Approval Date : 2016-09-13

Application Number : 113839005

Regulatory Info : Authorized

Registration Country : Spain

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11

AAPS
Not Confirmed
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Film Coated Tablet

Dosage Strength : 30MG

Packaging :

Approval Date : 2016-09-13

Application Number : 113839006

Regulatory Info : Authorized

Registration Country : Spain

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12

AAPS
Not Confirmed
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AAPS
Not Confirmed

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Packaging :

Approval Date : 2012-12-14

Application Number : 203469

Regulatory Info : RX

Registration Country : USA

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13

AAPS
Not Confirmed
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AAPS
Not Confirmed

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 45MG BASE

Packaging :

Approval Date : 2012-12-14

Application Number : 203469

Regulatory Info : RX

Registration Country : USA

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14

AAPS
Not Confirmed
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AAPS
Not Confirmed

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Packaging :

Approval Date : 2015-04-23

Application Number : 203469

Regulatory Info : RX

Registration Country : USA

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15

AAPS
Not Confirmed
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AAPS
Not Confirmed

PONATINIB HYDROCHLORIDE

Brand Name : ICLUSIG

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-12-18

Application Number : 203469

Regulatory Info : RX

Registration Country : USA

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16

ARIAD PHARMA LTD

Country
AAPS
Not Confirmed
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ARIAD PHARMA LTD

Country
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Ponatinib 15Mg 60 Units Oral Use

Dosage Strength : 60 cpr riv 15 mg vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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17

ARIAD PHARMA LTD

Country
AAPS
Not Confirmed
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ARIAD PHARMA LTD

Country
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Ponatinib 45Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr riv 45 mg vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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18

Incyte Biosciences UK Ltd

Country
AAPS
Not Confirmed
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Incyte Biosciences UK Ltd

Country
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 15 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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19

Incyte Biosciences UK Ltd

Country
AAPS
Not Confirmed
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Incyte Biosciences UK Ltd

Country
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AAPS
Not Confirmed

Ponatinib

Brand Name : Iclusig

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 45 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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20

TAKEDA PHARMACEUTICALS U.S.A., INC.

Country
AAPS
Not Confirmed
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TAKEDA PHARMACEUTICALS U.S.A., INC.

Country
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AAPS
Not Confirmed

PONATINIB (PONATINIB HYDROCHLORIDE)

Brand Name : ICLUSIG

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging : 60/180

Approval Date :

Application Number : 2437333

Regulatory Info : Prescription

Registration Country : Canada

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