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01 4Alexion Pharmaceuticals

02 12AstraZeneca

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PharmaCompass

01

PREP
Not Confirmed
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Selumetinib

Brand Name : Koselugo

Dosage Form : Hard Capsule

Dosage Strength : 10mg

Packaging :

Approval Date : 29/07/2022

Application Number : 67410

Regulatory Info : Allowed

Registration Country : Switzerland

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02

PREP
Not Confirmed
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PREP
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Selumetinib

Brand Name : Koselugo

Dosage Form : Hard Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 29/07/2022

Application Number : 67410

Regulatory Info : Allowed

Registration Country : Switzerland

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03

PREP
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PREP
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Selumetinib

Brand Name : Koselugo

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib

Brand Name : Koselugo

Dosage Form :

Dosage Strength :

Packaging : 60

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

PREP
Not Confirmed
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PREP
Not Confirmed

SELUMETINIB SULFATE

Brand Name : KOSELUGO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2020-04-10

Application Number : 213756

Regulatory Info : RX

Registration Country : USA

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06

PREP
Not Confirmed
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PREP
Not Confirmed

SELUMETINIB SULFATE

Brand Name : KOSELUGO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 25MG BASE

Packaging :

Approval Date : 2020-04-10

Application Number : 213756

Regulatory Info : RX

Registration Country : USA

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07

PREP
Not Confirmed
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PREP
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SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : GRANULE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 219943

Regulatory Info :

Registration Country : USA

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08

PREP
Not Confirmed
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PREP
Not Confirmed

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : GRANULE;ORAL

Dosage Strength : 7.5mg

Packaging :

Approval Date :

Application Number : 219943

Regulatory Info :

Registration Country : USA

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09

PREP
Not Confirmed
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PREP
Not Confirmed

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : CAPSULE; ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 219943

Regulatory Info :

Registration Country : USA

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10

PREP
Not Confirmed
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PREP
Not Confirmed

SELUMETINIB

Brand Name : KOSELUGO

Dosage Form : CAPSULE; ORAL

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number : 219943

Regulatory Info :

Registration Country : USA

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11

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib Sulfate

Brand Name : Kiss Logo

Dosage Form : Capsule

Dosage Strength : 10mg

Packaging :

Approval Date : 17/06/2021

Application Number : 20200310000040

Regulatory Info : Approved

Registration Country : Sweden

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12

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib Sulfate

Brand Name : Kiss Logo

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 17/06/2021

Application Number : 20200310000057

Regulatory Info : Approved

Registration Country : Sweden

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13

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib

Brand Name : Koselugo

Dosage Form : CAP

Dosage Strength : 10mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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14

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib

Brand Name : Koselugo

Dosage Form : CAP

Dosage Strength : 25mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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15

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib Sulfate

Brand Name : Koselugo

Dosage Form : Hard Capsule

Dosage Strength : 25MG

Packaging :

Approval Date : 2021-07-27

Application Number : 1211552002

Regulatory Info : Authorized

Registration Country : Spain

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16

PREP
Not Confirmed
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PREP
Not Confirmed

Selumetinib Sulfate

Brand Name : Koselugo

Dosage Form : Hard Capsule

Dosage Strength : 10MG

Packaging :

Approval Date : 2021-07-27

Application Number : 1211552001

Regulatory Info : Authorized

Registration Country : Spain

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