01 31Boehringer Ingelheim GmbH
02 4Genepharma Sa
03 3MARCAN PHARMACEUTICALS INC
04 3MSN Laboratories
05 3Pinnacle Life Science
06 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 12Film Coated Tablet
08 9TABLET
09 6TABLET;ORAL
10 3Tablet
11 6Blank
01 8Approved
02 4Authorized
03 3Originator
04 9Prescription
05 3RX
06 20Blank
01 3AFATINIB
02 3Afatinib
03 3GILOTRIF
04 3GIOTRIF
05 22Giotrif
06 1Giotrif 20 mg
07 1Giotrif 30 mg
08 1Giotrif 40 mg
09 3MAR-AFATINIB
10 3SANDOZ AFATINIB
11 4Webrix
01 6Australia
02 9Canada
03 3India
04 4Italy
05 4Norway
06 3South Africa
07 4Spain
08 8Sweden
09 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 : 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 : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
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 : India
Brand Name : Afatinib
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Afatinib
Dosage Form : Tablet
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Afatinib
Dosage Form : Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
