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01 1Biodeal Pharmaceuticals

02 2Bioron Pharma

03 2Eurocept Pharmaceuticals

04 2International Drug Development

05 3Janssen-Cilag

06 20Johnson & Johnson Innovative Medicine

07 2Kalcex

08 4ORIFARM GROUP AS

09 2Pfizer Inc

10 2SINTETICA SA

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PharmaCompass

01

PREP
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Esketamine Hydrochloride

Brand Name : Esketamine

Dosage Form : Nasal Spray

Dosage Strength : 14MG

Packaging : 1x1ml HDPE Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

PREP
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Esketamine

Brand Name : BRP-343

Dosage Form :

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

PREP
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Not Confirmed

Cannabidiol; Esketamine

Brand Name : BRP-412

Dosage Form : Oral

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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04

PREP
Not Confirmed
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Esketamine Hydrochloride

Brand Name : Sinmelan

Dosage Form : Injectable Solution

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 31/07/2018

Application Number : 20170502000045

Regulatory Info : Approved

Registration Country : Sweden

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05

PREP
Not Confirmed
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Esketamine Hydrochloride

Brand Name : Sinmelan

Dosage Form : Injectable Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 31/07/2018

Application Number : 20170502000038

Regulatory Info : Approved

Registration Country : Sweden

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06

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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07

PREP
Not Confirmed
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Esketamine Hydrochloride

Brand Name : Spravato

Dosage Form : Inhalation Spray

Dosage Strength : 28mg

Packaging :

Approval Date : 18/12/2019

Application Number : 20181012000036

Regulatory Info : Approved

Registration Country : Sweden

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08

PREP
Not Confirmed
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ESKETAMINE HYDROCHLORIDE

Brand Name : SPRAVATO

Dosage Form : SPRAY;NASAL

Dosage Strength : EQ 28MG BASE

Packaging :

Approval Date : 2019-03-05

Application Number : 211243

Regulatory Info : RX

Registration Country : USA

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09

PREP
Not Confirmed
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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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10

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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11

PREP
Not Confirmed
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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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12

PREP
Not Confirmed
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PREP
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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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13

PREP
Not Confirmed
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Esketamine Hydrochloride

Brand Name : Ketanest

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 28/06/2017

Application Number : 20161025000049

Regulatory Info : Deregistered

Registration Country : Sweden

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14

PREP
Not Confirmed
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PREP
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Esketamine Hydrochloride

Brand Name : Ketanest

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 28/06/2017

Application Number : 20161025000032

Regulatory Info : Deregistered

Registration Country : Sweden

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15

PREP
Not Confirmed
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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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16

PREP
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PREP
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Esketamine Hydrochloride

Brand Name : Ketanest

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 01/08/2013

Application Number : 20130105000064

Regulatory Info : Approved

Registration Country : Sweden

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17

PREP
Not Confirmed
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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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18

PREP
Not Confirmed
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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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19

International Drug Development

Country
PREP
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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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20

International Drug Development

Country
PREP
Not Confirmed
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International Drug Development

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PREP
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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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