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01 2As Kalceks

02 2Eurocept International Bv

03 2International Drug Development

04 1Janssen - Cilag International

05 1Janssen-Cilag Ag

06 1Janssen-Cilag International N.V.

07 3Janssen-Cilag International NV

08 4Janssen-Cilag International Nv

09 2Kalceks As

10 2Orifarm Ab

11 4Orifarm Generics A/S

12 2PFIZER AS

13 2Pfizer Ab

14 2Pfizer Aps

15 2Sintetica Sa

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PharmaCompass

01

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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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 : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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02

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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 : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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03

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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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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04

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Esketamine

Brand Name : Spravato®

Dosage Form : Nasal Spray

Dosage Strength :

Packaging :

Approval Date : 01-07-2025

Application Number :

Regulatory Info :

Registration Country : Moldova

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05

BIO CEO & Investor
Not Confirmed
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BIO CEO & Investor
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Esketamine

Brand Name : Spravato

Dosage Form : Nasal Spray Solution

Dosage Strength : 28mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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06

euroPLX 90 Lisbon
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euroPLX 90 Lisbon
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Esketamine Hydrochloride

Brand Name : Spravato

Dosage Form : Solution For Nasal Spray

Dosage Strength : 28MG

Packaging :

Approval Date : 05-02-2020

Application Number : 1191410001

Regulatory Info : Authorized

Registration Country : Spain

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07

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
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Esketamine Hydrochloride

Brand Name : Esketamine Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 06-11-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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08

euroPLX 90 Lisbon
Not Confirmed
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euroPLX 90 Lisbon
Not Confirmed

Esketamine Hydrochloride

Brand Name : Esketamine Kalceks

Dosage Form : Solution For Injection/Infusion

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 06-11-2019

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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09

International Drug Development

Country
euroPLX 90 Lisbon
Not Confirmed
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International Drug Development

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euroPLX 90 Lisbon
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 : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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10

International Drug Development

Country
euroPLX 90 Lisbon
Not Confirmed
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International Drug Development

Country
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euroPLX 90 Lisbon
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 : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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