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01 1Estetra Sprl

02 3Gedeon Richter

03 1Mayne Pharma

04 1Mayne Pharma Do Brasil Ltda

05 1SEARCHLIGHT PHARMA

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PharmaCompass

01

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Drospirenone; Estetrol Monohydrate

Brand Name : Drovelis

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 19/05/2021

Application Number : 20200128000010

Regulatory Info : Approved

Registration Country : Sweden

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02

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Estetrolum; Drospirenonum

Brand Name : Drovelis

Dosage Form : Film Coated Tablet

Dosage Strength : 15mg;3mg

Packaging :

Approval Date : 05/05/2022

Application Number : 68228

Regulatory Info : Allowed

Registration Country : Switzerland

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03

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Drospyrenone; Estetrol Monohydrate

Brand Name : Drovelis

Dosage Form : Film Coated Tablet

Dosage Strength : 3MG; 14.2 MG

Packaging :

Approval Date : 2021-09-07

Application Number : 1211547001

Regulatory Info : Authorized

Registration Country : Spain

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04

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

DROSPIRENONE; ESTETROL

Brand Name : NEXTSTELLIS

Dosage Form : TABLET;ORAL

Dosage Strength : 3MG;14.2MG

Packaging :

Approval Date : 2021-04-15

Application Number : 214154

Regulatory Info : RX

Registration Country : USA

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05

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

Estetrol + drospirenone

Brand Name : Nextstellis

Dosage Form :

Dosage Strength :

Packaging : 3

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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06

CPhI India
Not Confirmed
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CPhI India
Not Confirmed

ESTETROL MONOHYDRATE

Brand Name : NEXTSTELLIS

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number : 2513218

Regulatory Info : Prescription

Registration Country : Canada

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07

Estetra Sprl

Country
CPhI India
Not Confirmed
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Estetra Sprl

Country
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CPhI India
Not Confirmed

Drospirenone; Estetrol Monohydrate

Brand Name : Lydisilka

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 19/05/2021

Application Number : 20200128000034

Regulatory Info : Approved

Registration Country : Sweden

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