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01 1Catalyst Pharmaceuticals

02 5Santhera Pharmaceuticals

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PharmaCompass

01

SCOPE Summit
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SCOPE Summit
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VAMOROLONE

Brand Name : AGAMREE

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 40MG/ML

Packaging :

Approval Date : 2023-10-26

Application Number : 215239

Regulatory Info : RX

Registration Country : USA

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02

SCOPE Summit
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SCOPE Summit
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Vamorolon

Brand Name : Culture

Dosage Form : Oral Suspension

Dosage Strength : 40mg/ml

Packaging :

Approval Date : 14/12/2023

Application Number : 20220930000022

Regulatory Info : Approved

Registration Country : Sweden

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03

SCOPE Summit
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SCOPE Summit
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Vamorolone

Brand Name : Agamree

Dosage Form : Oral Suspension

Dosage Strength : 40mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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04

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Vamorolone

Brand Name : Agamree

Dosage Form : Oral Suspension

Dosage Strength : 40mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Vamorolona

Brand Name : Agamree

Dosage Form : Oral Suspension

Dosage Strength : 40MG

Packaging :

Approval Date : 09-05-2024

Application Number : 1231776001

Regulatory Info : Authorized

Registration Country : Spain

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Vamorolone

Brand Name : Agamree

Dosage Form : Oral Suspension

Dosage Strength : 40mg/ml

Packaging :

Approval Date : 14-12-2023

Application Number : 28106847322

Regulatory Info : Prescription

Registration Country : Denmark

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