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01 1HELSINN BIREX PHARMAC.LTD
02 1Helsinn Birex Pharmaceuticals Limited
03 1Helsinn Birex Pharmaceuticals Ltd
04 1Medius Ag
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01 1Netupitant; Palonosetron
02 1Netupitant; Palonosetron Hydrochloride
03 1Netupitantum; Palonosetronum
04 1Palonosetron Hydrochloride; Netupitant
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01 2Capsule
02 1Hard Capsule
03 1Netupitant+Palonosetron 0,5+300Mg 1 Combined Oral Use
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01 1Italy
02 1Spain
03 1Sweden
04 1Switzerland
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01 3Akynzeo
02 1Akynzeo
Regulatory Info :
Registration Country : Italy
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Authorized
Registration Country : Spain
Palonosetron Hydrochloride; Netupitant
Brand Name : Akynzeo
Dosage Form : Hard Capsule
Dosage Strength : 300MG; 0.5 MG
Packaging :
Approval Date : 2015-10-02
Application Number : 1151001001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
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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