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01 3B Braun Medical Sa

02 1Ewopharma Ag

03 1Fresenius Kabi Ab

04 1Fresenius Kabi Espa?a, Sau

05 2Ideogen Ag

06 1Insmed Netherlands Bv

07 1Macure Pharma Aps

08 2Noridem Enterprises Limited

09 1Normon Laboratories Sa

10 3Omnia L?kemedel Ab

11 1Orifarm AS

12 2Orifarm Ab

13 1Reig Jofre Laboratory, Sa

14 1Tillomed Pharma Gmbh

15 1Vianex Sa

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PharmaCompass

01

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Amikacin Sulfate

Brand Name : Amikacin Fresenius Kabi

Dosage Form : Infusion Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 04/06/2020

Application Number : 20180515000017

Regulatory Info : Approved

Registration Country : Sweden

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02

PREP
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Amikacin Sulfate

Brand Name : Arikayce Liposomal

Dosage Form : Dispersion For Nebulizer

Dosage Strength : 590mg

Packaging :

Approval Date : 27/10/2020

Application Number : 20190708000014

Regulatory Info : Approved

Registration Country : Sweden

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03

PREP
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Amikacin Sulfate

Brand Name : Amikacin Macure

Dosage Form : Injectable Solution

Dosage Strength : 250mg/ml

Packaging :

Approval Date : 30/07/2020

Application Number : 20190328000098

Regulatory Info : Approved

Registration Country : Sweden

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04

PREP
Not Confirmed
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Amikacin sulfate

Brand Name : Amikacin Orifarm

Dosage Form : Solution for injection

Dosage Strength : 250 mg/ml

Packaging : Vials 2ml

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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05

PREP
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PREP
Not Confirmed

Amikacin Sulfate

Brand Name : Amikacin Orifarm

Dosage Form : Injectable Solution

Dosage Strength : 250mg/ml

Packaging :

Approval Date : 07/11/2023

Application Number : 20230530000018

Regulatory Info : Approved

Registration Country : Sweden

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06

PREP
Not Confirmed
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PREP
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Amikacin Sulfate

Brand Name : Amikacin Tillomed

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 250mg/ml

Packaging :

Approval Date : 03/05/2019

Application Number : 20180404000159

Regulatory Info : Deregistered

Registration Country : Sweden

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07

Ewopharma Ag

Country
PREP
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Ewopharma Ag

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PREP
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Amikacin

Brand Name : Amikin

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 500mg/2ml

Packaging :

Approval Date : 25/05/1976

Application Number : 39805

Regulatory Info : Allowed

Registration Country : Switzerland

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08

Vianex Sa

Country
PREP
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Vianex Sa

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PREP
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Amikacin Sulfate

Brand Name : Bikeline

Dosage Form : Injectable Solution

Dosage Strength : 250mg/ml

Packaging :

Approval Date : 19/10/1979

Application Number : 19791019000010

Regulatory Info : Approved

Registration Country : Sweden

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09

Omnia L?kemedel Ab

Country
PREP
Not Confirmed
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Omnia L?kemedel Ab

Country
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PREP
Not Confirmed

Amikacin Sulfate

Brand Name : Bikeline

Dosage Form : Injectable Solution

Dosage Strength : 250mg/ml

Packaging :

Approval Date : 05/05/2010

Application Number : 20100112000074

Regulatory Info : Deregistered

Registration Country : Sweden

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10

Omnia L?kemedel Ab

Country
PREP
Not Confirmed
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Omnia L?kemedel Ab

Country
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PREP
Not Confirmed

Amikacin Sulfate

Brand Name : Bikeline

Dosage Form : Injectable Solution

Dosage Strength : 250mg/ml

Packaging :

Approval Date : 11/05/2016

Application Number : 20160301000063

Regulatory Info : Deregistered

Registration Country : Sweden

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