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01 31Boehringer Ingelheim GmbH

02 4Genepharma Sa

03 3MARCAN PHARMACEUTICALS INC

04 3MSN Laboratories

05 3Pinnacle Life Science

06 3Sandoz B2B

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PharmaCompass

01

FNCE
Not Confirmed
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FNCE
Not Confirmed

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Packaging :

Approval Date : 2013-07-12

Application Number : 201292

Regulatory Info : RX

Registration Country : USA

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02

FNCE
Not Confirmed
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FNCE
Not Confirmed

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 30MG BASE

Packaging :

Approval Date : 2013-07-12

Application Number : 201292

Regulatory Info : RX

Registration Country : USA

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03

FNCE
Not Confirmed
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FNCE
Not Confirmed

AFATINIB DIMALEATE

Brand Name : GILOTRIF

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 40MG BASE

Packaging :

Approval Date : 2013-07-12

Application Number : 201292

Regulatory Info : RX

Registration Country : USA

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04

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Afatinib 20Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 20 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

afatinib

Brand Name : Giotrif

Dosage Form : Afatinib 30Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 30 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Afatinib 40Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 40 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Afatinib 50Mg 28 Combined Oral Use

Dosage Strength : 28 cpr riv 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 20 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 30 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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10

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 40 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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11

FNCE
Not Confirmed
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FNCE
Not Confirmed

afatinib

Brand Name : Giotrif

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 50 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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12

FNCE
Not Confirmed
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FNCE
Not Confirmed

Afatinib Dimaleate

Brand Name : Giotrif

Dosage Form : Film Coated Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 2013-09-25

Application Number : 20120831000018

Regulatory Info : Approved

Registration Country : Sweden

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13

FNCE
Not Confirmed
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FNCE
Not Confirmed

Afatinib Dimaleate

Brand Name : Giotrif

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 2013-09-25

Application Number : 20120831000025

Regulatory Info : Approved

Registration Country : Sweden

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14

FNCE
Not Confirmed
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FNCE
Not Confirmed

Afatinib Dimaleate

Brand Name : Giotrif

Dosage Form : Film Coated Tablet

Dosage Strength : 40mg

Packaging :

Approval Date : 2013-09-25

Application Number : 20120831000032

Regulatory Info : Approved

Registration Country : Sweden

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15

FNCE
Not Confirmed
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FNCE
Not Confirmed

AFATINIB

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 210804

Regulatory Info :

Registration Country : USA

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16

FNCE
Not Confirmed
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FNCE
Not Confirmed

AFATINIB

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number : 210804

Regulatory Info :

Registration Country : USA

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17

FNCE
Not Confirmed
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FNCE
Not Confirmed

AFATINIB

Brand Name : AFATINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number : 210804

Regulatory Info :

Registration Country : USA

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18

FNCE
Not Confirmed
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FNCE
Not Confirmed

Afatinib

Brand Name : Afatinib

Dosage Form : Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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19

FNCE
Not Confirmed
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FNCE
Not Confirmed

Afatinib

Brand Name : Afatinib

Dosage Form : Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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20

FNCE
Not Confirmed
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FNCE
Not Confirmed

Afatinib

Brand Name : Afatinib

Dosage Form : Tablet

Dosage Strength : 40MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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