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01 2As Kalceks

02 2Eurocept International Bv

03 2International Drug Development

04 1Janssen-Cilag Ag

05 1Janssen-Cilag International N.V.

06 1Janssen-Cilag International Nv

07 2Orifarm Ab

08 2Orifarm Generics A/S

09 2Pfizer Ab

10 2Sintetica Sa

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PharmaCompass

01

PREP
Not Confirmed
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Esketamine

Brand Name : Spravato

Dosage Form : Nasal Spray Solution

Dosage Strength : 28mg/spray

Packaging :

Approval Date : 25/02/2020

Application Number : 67103

Regulatory Info : Allowed

Registration Country : Switzerland

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02

PREP
Not Confirmed
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PREP
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Esketamine Hydrochloride

Brand Name : Esketamine Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 06/11/2019

Application Number : 20181129000097

Regulatory Info : Approved

Registration Country : Sweden

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03

PREP
Not Confirmed
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PREP
Not Confirmed

Esketamine Hydrochloride

Brand Name : Esketamine Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 06/11/2019

Application Number : 20181129000080

Regulatory Info : Approved

Registration Country : Sweden

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04

PREP
Not Confirmed
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PREP
Not Confirmed

Esketamine Hydrochloride

Brand Name : Esketamine Orifarm

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 11/06/2019

Application Number : 20171201000060

Regulatory Info : Approved

Registration Country : Sweden

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05

PREP
Not Confirmed
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PREP
Not Confirmed

Esketamine Hydrochloride

Brand Name : Esketamine Orifarm

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 11/06/2019

Application Number : 20171201000053

Regulatory Info : Approved

Registration Country : Sweden

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06

PREP
Not Confirmed
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PREP
Not Confirmed

Esketamine Hydrochloride

Brand Name : Ketanest

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 01/08/2013

Application Number : 20130105000071

Regulatory Info : Approved

Registration Country : Sweden

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07

PREP
Not Confirmed
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PREP
Not Confirmed

Esketamine

Brand Name : Esketamine Sintetica

Dosage Form : Injectable Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 19/11/2021

Application Number : 67994

Regulatory Info : Allowed

Registration Country : Switzerland

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08

PREP
Not Confirmed
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PREP
Not Confirmed

Esketamine

Brand Name : Esketamine Sintetica

Dosage Form : Injectable Solution

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 19/11/2021

Application Number : 67994

Regulatory Info : Allowed

Registration Country : Switzerland

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09

International Drug Development

Country
PREP
Not Confirmed
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International Drug Development

Country
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PREP
Not Confirmed

Esketamine Hydrochloride

Brand Name : Esketamine Idd

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 18/01/2019

Application Number : 20171020000067

Regulatory Info : Approved

Registration Country : Sweden

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10

International Drug Development

Country
PREP
Not Confirmed
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International Drug Development

Country
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PREP
Not Confirmed

Esketamine Hydrochloride

Brand Name : Esketamine Idd

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 18/01/2019

Application Number : 20171020000050

Regulatory Info : Approved

Registration Country : Sweden

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