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01 1HELSINN BIREX PHARMAC.LTD

02 4Helsinn Birex Pharmaceuticals Limited

03 1Helsinn Birex Pharmaceuticals Lt

04 2Helsinn Birex Pharmaceuticals Ltd

05 1Medius Ag

06 1Orifarm AS

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PharmaCompass

01

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Netupitant; Palonosetron

Brand Name : Akynzeo

Dosage Form : Netupitant+Palonosetron 0,5+300Mg 1 Combined Oral Use

Dosage Strength : 1 cps 300 mg + 0.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Netupitant; Palonosetron Hydrochloride

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300mg/0.5mg

Packaging :

Approval Date : 27/05/2015

Application Number : 20140125000029

Regulatory Info : Approved

Registration Country : Sweden

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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Netupitant; Palonosetron hydrochloride

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300mg; 0.5mg

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
Not Confirmed

Palonosetron; Netupitant

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 0.5mg; 300mg

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
Not Confirmed

Palonosetron; Netupitant

Brand Name : Akynzeo

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 250mcg; 235mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Palonosetron; Netupitant

Brand Name : Akynzeo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 250mcg; 235mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Palonosetron Hydrochloride; Netupitant

Brand Name : Akynzeo

Dosage Form : Hard Capsule

Dosage Strength : 300MG; 0.5 MG

Packaging :

Approval Date : 02-10-2015

Application Number : 1151001001

Regulatory Info : Authorized

Registration Country : Spain

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Netupitant; Palonosetron hydrochloride

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300mg; 0.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

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09

Medius Ag

Country
SCOPE Summit
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Medius Ag

Country
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SCOPE Summit
Not Confirmed

Netupitantum; Palonosetronum

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300 mg;0.5mg

Packaging :

Approval Date : 06/11/2015

Application Number : 65499

Regulatory Info : Allowed

Registration Country : Switzerland

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10

Helsinn Birex Pharmaceuticals Lt

Country
SCOPE Summit
Not Confirmed
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Helsinn Birex Pharmaceuticals Lt

Country
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SCOPE Summit
Not Confirmed

Netupitant; Palonosetron Hydrochloride

Brand Name : Akynzeo

Dosage Form : Hard Capsules

Dosage Strength : 300mg; 0.5mg

Packaging :

Approval Date : 27-05-2015

Application Number : 28105375314

Regulatory Info : Prescription

Registration Country : Denmark

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