01 32Boehringer Ingelheim GmbH
02 3MSN Laboratories
03 3Sandoz B2B
01 1Afatinib 20Mg 28 Combined Oral Use
02 1Afatinib 30Mg 28 Combined Oral Use
03 1Afatinib 40Mg 28 Combined Oral Use
04 1Afatinib 50Mg 28 Combined Oral Use
05 4Antic-calc Tablet, Film Coated
06 3FCR
07 4FILM COATED PILL
08 3Filmtabl
09 6TABLET
10 6TABLET;ORAL
11 8Blank
01 3Originator
02 3RX
03 32Blank
01 3AFATINIB
02 3GILOTRIF
03 7GIOTRIF
04 19Giotrif
05 1Giotrif 20 mg
06 1Giotrif 30 mg
07 1Giotrif 40 mg
08 3SANDOZ AFATINIB
01 8Australia
02 6Canada
03 4Italy
04 4Norway
05 3South Africa
06 4Sweden
07 3Switzerland
08 6USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Sweden
Brand Name : GIOTRIF
Dosage Form : FILM COATED PILL
Dosage Strength : 20 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : GIOTRIF
Dosage Form : FILM COATED PILL
Dosage Strength : 30 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : GIOTRIF
Dosage Form : FILM COATED PILL
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : GIOTRIF
Dosage Form : FILM COATED PILL
Dosage Strength : 40 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Norway
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
Regulatory Info :
Registration Country : Switzerland
Brand Name : Giotrif
Dosage Form : Filmtabl
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Giotrif
Dosage Form : Filmtabl
Dosage Strength : 30mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Giotrif
Dosage Form : Filmtabl
Dosage Strength : 40mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Canada
Brand Name : GIOTRIF
Dosage Form : TABLET
Dosage Strength : 20MG
Packaging : 28
Approval Date :
Application Number : 2415666
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GIOTRIF
Dosage Form : TABLET
Dosage Strength : 30MG
Packaging : 14/28
Approval Date :
Application Number : 2415674
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : GIOTRIF
Dosage Form : TABLET
Dosage Strength : 40MG
Packaging : 14/28
Approval Date :
Application Number : 2415682
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Giotrif
Dosage Form :
Dosage Strength :
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Giotrif
Dosage Form :
Dosage Strength :
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Giotrif
Dosage Form :
Dosage Strength :
Packaging : 28
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : USA
Brand Name : AFATINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number : 210804
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AFATINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number : 210804
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AFATINIB
Dosage Form : TABLET;ORAL
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number : 210804
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : SANDOZ AFATINIB
Dosage Form : TABLET
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number : 2512785
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SANDOZ AFATINIB
Dosage Form : TABLET
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number : 2512793
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SANDOZ AFATINIB
Dosage Form : TABLET
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number : 2512777
Regulatory Info :
Registration Country : Canada
