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01 1FARMITALIA Srl

02 1Labatec Pharma Sa

03 1Laboratoire Theramex

04 1Merck Sharp & Dohme Limited

05 2RATIOPHARM ITALIA Srl

06 2Teva Bv

07 7Theramex Ireland Limited

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PharmaCompass

01

IPPE
Not Confirmed
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IPPE
Not Confirmed

nomegestrol

Brand Name : Nomegestrol

Dosage Form : Nomegestrolo 5Mg 30 Joined' Oral Use

Dosage Strength : 30 CPR 5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

IPPE
Not Confirmed
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IPPE
Not Confirmed

Estradiol; Nomegestrol Acetate

Brand Name : Zoely

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 19/07/2012

Application Number : 61355

Regulatory Info : Allowed

Registration Country : Switzerland

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03

IPPE
Not Confirmed
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IPPE
Not Confirmed

Nomegestrol Acetate

Brand Name : Lutenyl

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date : 2006-04-13

Application Number :

Regulatory Info : Withdrawn

Registration Country : Malta

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04

IPPE
Not Confirmed
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IPPE
Not Confirmed

Estradiol Hemihydrate; Nomegestrol Acetate

Brand Name : Ioa

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg;1.5mg

Packaging :

Approval Date : 16/11/2011

Application Number : 20100226000021

Regulatory Info : Deregistered

Registration Country : Sweden

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05

IPPE
Not Confirmed
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IPPE
Not Confirmed

Estradiol; nomegestrol

Brand Name : Naemis

Dosage Form : Estradiol+Nomegestrolo 1.5 Mg 10 Units + 1,5 + 3,75 Mg 14 Joined' Oral Use

Dosage Strength : 10 cpr rosa 1.5 mg and 14 white cpr 1.5 mg + 3.75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

IPPE
Not Confirmed
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IPPE
Not Confirmed

nomegestrol

Brand Name : Lutenyl

Dosage Form : Nomegestrolo 5Mg 30 Joined' Oral Use

Dosage Strength : 30 CPR 5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

IPPE
Not Confirmed
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IPPE
Not Confirmed

Estradiol Hemihydrate; Nomegestrol Acetate

Brand Name : Zoely

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5MG; 1.5 MG

Packaging :

Approval Date : 14-03-2017

Application Number : 11690001IP

Regulatory Info : Authorized

Registration Country : Spain

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08

IPPE
Not Confirmed
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IPPE
Not Confirmed

Estradiol Hemihydrate; Nomegestrol Acetate

Brand Name : Zoely

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg;1.5mg

Packaging :

Approval Date : 27/07/2011

Application Number : 20090917000020

Regulatory Info : Approved

Registration Country : Sweden

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09

IPPE
Not Confirmed
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IPPE
Not Confirmed

Nomegestrol acetate; Estradiol hemihydrate

Brand Name : Zoely

Dosage Form : Film Coated Tablet

Dosage Strength : 2.5mg; 1.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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10

IPPE
Not Confirmed
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IPPE
Not Confirmed

Nomegestrol; Estradiol

Brand Name : Zoely

Dosage Form : Film-Coated Tablet

Dosage Strength : 0.25mg; 15mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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