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01 5Helsinn Advanced Synthesis
02 1Medius Ag
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01 2Concentrate For Solution For Infusion
02 1POWDER;INTRAVENOUS
03 2Powder For Concentrate For Solution For Infusion
04 1SOLUTION;INTRAVENOUS
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01 1Allowed
02 2Approved
03 1Authorized
04 1DISCN
05 1RX
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01 2AKYNZEO
02 3Akynzeo
03 1Akynzeo IV
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01 1Spain
02 2Sweden
03 1Switzerland
04 2USA
Regulatory Info : DISCN
Registration Country : USA
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Brand Name : AKYNZEO
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
Packaging :
Approval Date : 2018-04-19
Application Number : 210493
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE
Brand Name : AKYNZEO
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
Packaging :
Approval Date : 2020-05-27
Application Number : 210493
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Approved
Registration Country : Sweden
Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride
Brand Name : Akynzeo
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 235mg/0.25mg
Packaging :
Approval Date : 12/11/2021
Application Number : 20200916000079
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride
Brand Name : Akynzeo
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 235mg/0.25mg
Packaging :
Approval Date : 16/03/2020
Application Number : 20181108000049
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Palonosetron Hydrochloride; Fosnetupitant
Brand Name : Akynzeo
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 235MG; 0.25 MG
Packaging :
Approval Date : 2020-06-10
Application Number : 1151001003
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Akynzeo IV
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 235mg;0.25mg
Packaging :
Approval Date : 01/09/2022
Application Number : 68290
Regulatory Info : Allowed
Registration Country : Switzerland
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