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01 8Bioprojet Pharma

02 2Future Health Pharma Gmbh

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PharmaCompass

01

Fall Technical Meeting
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Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 18mg

Packaging :

Approval Date : 22/07/2021

Application Number : 20191110000029

Regulatory Info : Approved

Registration Country : Sweden

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02

Fall Technical Meeting
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Fall Technical Meeting
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Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5mg

Packaging :

Approval Date : 22/07/2021

Application Number : 20191110000012

Regulatory Info : Approved

Registration Country : Sweden

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03

Fall Technical Meeting
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Fall Technical Meeting
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Pitolisant Hydrochloride

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 18mg

Packaging :

Approval Date : 31/03/2016

Application Number : 20140610000015

Regulatory Info : Approved

Registration Country : Sweden

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04

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
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Pitolisant Hydrochloride

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5mg

Packaging :

Approval Date : 31/03/2016

Application Number : 20151003000024

Regulatory Info : Approved

Registration Country : Sweden

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05

Fall Technical Meeting
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Fall Technical Meeting
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Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5MG

Packaging :

Approval Date : 2021-11-11

Application Number : 1211546001

Regulatory Info : Authorized

Registration Country : Spain

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06

Fall Technical Meeting
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Fall Technical Meeting
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Pitolisant Hydrochloride

Brand Name : Ozawade

Dosage Form : Film Coated Tablet

Dosage Strength : 18MG

Packaging :

Approval Date : 2021-11-11

Application Number : 1211546002

Regulatory Info : Authorized

Registration Country : Spain

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07

Fall Technical Meeting
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Fall Technical Meeting
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Pitolisant

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 4.5MG

Packaging :

Approval Date : 2016-09-03

Application Number : 1151068001

Regulatory Info : Authorized

Registration Country : Spain

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08

Fall Technical Meeting
Not Confirmed
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Fall Technical Meeting
Not Confirmed

Pitolisant

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 18MG

Packaging :

Approval Date : 2016-08-03

Application Number : 1151068002

Regulatory Info : Authorized

Registration Country : Spain

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09

Future Health Pharma Gmbh

Country
Fall Technical Meeting
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Future Health Pharma Gmbh

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Fall Technical Meeting
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Pitolisant

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 4.45mg

Packaging :

Approval Date : 20/12/2018

Application Number : 67007

Regulatory Info : Allowed

Registration Country : Switzerland

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10

Future Health Pharma Gmbh

Country
Fall Technical Meeting
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Future Health Pharma Gmbh

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Fall Technical Meeting
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Pitolisant

Brand Name : Wakix

Dosage Form : Film Coated Tablet

Dosage Strength : 17.8mg

Packaging :

Approval Date : 20/12/2018

Application Number : 67007

Regulatory Info : Allowed

Registration Country : Switzerland

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