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01 1Medius Ag

02 1Recordati (Netherlands) Bv

03 1Recordati Netherlands B.V

04 1Recordati Netherlands B.V.

05 1Recordati Netherlands BV

06 1Recordati Netherlands Bv

07 1United Therapeutics Europe, Ltd

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PharmaCompass

01

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dinutuximab Beta

Brand Name : Qarziba

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 4.5mg/mL

Packaging :

Approval Date : 08/05/2017

Application Number : 20150513000012

Regulatory Info : Approved

Registration Country : Sweden

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02

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dinutuximab beta

Brand Name : Qarziba

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 4.5mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dinutuximab beta

Brand Name : Qarziba

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 45mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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04

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dinutuximab Beta

Brand Name : Qarziba

Dosage Form : Concentrate For Infusion Solution

Dosage Strength : 4.5MG

Packaging :

Approval Date : 06-09-2018

Application Number : 1171191001

Regulatory Info : Authorized

Registration Country : Spain

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05

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dinutuximab Beta

Brand Name : Qarziba

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 4.5mg/ml

Packaging :

Approval Date : 08-05-2017

Application Number : 28105605715

Regulatory Info : Prescription

Registration Country : Denmark

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Dinutuximab

Brand Name : Unituxin

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 3.5mg/ml

Packaging :

Approval Date : 14/08/2015

Application Number : 20131231000072

Regulatory Info : Deregistered

Registration Country : Sweden

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07

Medius Ag

Country
SCOPE Summit
Not Confirmed
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Medius Ag

Country
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SCOPE Summit
Not Confirmed

Dinutuximabum Beta

Brand Name : Qarziba

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 20.25mg/4.5ml

Packaging :

Approval Date : 18/04/2024

Application Number : 67463

Regulatory Info : Allowed

Registration Country : Switzerland

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