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01 6Alexion Pharmaceuticals

02 20AstraZeneca

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PharmaCompass

01

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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04

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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05

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

SELUMETINIB SULFATE

Brand Name : KOSELUGO

Dosage Form : GRANULE;ORAL

Dosage Strength : EQ 5MG BASE

Packaging :

Approval Date : 2025-09-10

Application Number : 219943

Regulatory Info : RX

Registration Country : USA

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06

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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SELUMETINIB SULFATE

Brand Name : KOSELUGO

Dosage Form : GRANULE;ORAL

Dosage Strength : EQ 7.5MG BASE

Packaging :

Approval Date : 2025-09-10

Application Number : 219943

Regulatory Info : RX

Registration Country : USA

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07

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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08

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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09

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib sulfate

Brand Name : Kiss logo

Dosage Form : Capsule

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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10

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib sulfate

Brand Name : Kiss logo

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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11

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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selumetinib

Brand Name : Koselugo

Dosage Form : Capsule

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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12

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

selumetinib

Brand Name : Koselugo

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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13

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib Sulfate

Brand Name : Koselugo

Dosage Form : Hard Capsule

Dosage Strength : 25MG

Packaging :

Approval Date : 27-07-2021

Application Number : 1211552002

Regulatory Info : Authorized

Registration Country : Spain

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14

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib Sulfate

Brand Name : Koselugo

Dosage Form : Hard Capsule

Dosage Strength : 10MG

Packaging :

Approval Date : 27-07-2021

Application Number : 1211552001

Regulatory Info : Authorized

Registration Country : Spain

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15

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib Sulfate

Brand Name : Koselugo

Dosage Form : Hard Capsules

Dosage Strength : 10mg

Packaging :

Approval Date : 19-06-2021

Application Number : 28106418020

Regulatory Info : Prescription

Registration Country : Denmark

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16

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib Sulfate

Brand Name : Koselugo

Dosage Form : Hard Capsules

Dosage Strength : 25mg

Packaging :

Approval Date : 19-06-2021

Application Number : 28106418120

Regulatory Info : Prescription

Registration Country : Denmark

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17

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib

Brand Name : Kiss Logo

Dosage Form : Capsule

Dosage Strength : 5mg

Packaging :

Approval Date : 09-01-2026

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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18

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib

Brand Name : Kiss Logo

Dosage Form : Capsule

Dosage Strength : 7.5mg

Packaging :

Approval Date : 09-01-2026

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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19

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib Sulfate

Brand Name : Kiss Logo

Dosage Form : Capsule

Dosage Strength : 10mg

Packaging :

Approval Date : 17-06-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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20

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Selumetinib Sulfate

Brand Name : Kiss Logo

Dosage Form : Capsule

Dosage Strength : 25mg

Packaging :

Approval Date : 17-06-2021

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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