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01 3A. Menarini Gmbh

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

03 3Menarini International Operation Luxembourg S.A.

04 7Menarini International Operations Luxembourg S.A.

05 10Menarini International Operations Luxembourg Sa

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PharmaCompass

01

BioProcess International US West
Not Confirmed
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BioProcess International US West
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

BioProcess International US West
Not Confirmed
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BioProcess International US West
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

BioProcess International US West
Not Confirmed
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BioProcess International US West
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

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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06

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 21-06-2013

Application Number : 28105080112

Regulatory Info : Prescription

Registration Country : Denmark

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07

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 21-06-2013

Application Number : 28105080212

Regulatory Info : Prescription

Registration Country : Denmark

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08

BioProcess International US West
Not Confirmed
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BioProcess International US West
Not Confirmed

Avanafil

Brand Name : Spedra

Dosage Form : Tablet

Dosage Strength : 50mg

Packaging :

Approval Date : 21-06-2013

Application Number : 28105080012

Regulatory Info : Prescription

Registration Country : Denmark

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09

BioProcess International US West
Not Confirmed
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BioProcess International US West
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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10

BioProcess International US West
Not Confirmed
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BioProcess International US West
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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