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01 3A. Menarini Gmbh

02 2MENARINI INTERNAT. O.L.S.A

03 10Menarini International Operations Luxembourg Sa

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 22/01/2016

Application Number : 65275

Regulatory Info : Allowed

Registration Country : Switzerland

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 22/01/2016

Application Number : 65275

Regulatory Info : Allowed

Registration Country : Switzerland

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 22/01/2016

Application Number : 65275

Regulatory Info : Allowed

Registration Country : Switzerland

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

Avanafil

Brand Name : Edra

Dosage Form : Avanafil 100Mg 12 Combined Oral Use

Dosage Strength : 12 CPR 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

FNCE
Not Confirmed
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FNCE
Not Confirmed

Avanafil

Brand Name : Edra

Dosage Form : Avanafil 200Mg 12 Combined Oral Use

Dosage Strength : 12 CPR 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

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FNCE
Not Confirmed

Avanafil

Brand Name : Spread

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 21/06/2013

Application Number : 20120413000054

Regulatory Info : Approved

Registration Country : Sweden

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07

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FNCE
Not Confirmed

Avanafil

Brand Name : Spread

Dosage Form : Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 21/06/2013

Application Number : 20120413000061

Regulatory Info : Approved

Registration Country : Sweden

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08

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FNCE
Not Confirmed

Avanafil

Brand Name : Spread

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 21/06/2013

Application Number : 20120413000047

Regulatory Info : Approved

Registration Country : Sweden

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09

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FNCE
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 2014-01-10

Application Number : 113841005

Regulatory Info : Authorized

Registration Country : Spain

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10

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FNCE
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date : 2014-01-10

Application Number : 113841008

Regulatory Info : Authorized

Registration Country : Spain

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