Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
GIOTRIF 20 mg film-coated tablets.
GIOTRIF 30 mg film-coated tablets.
GIOTRIF 40 mg film-coated tablets.
GIOTRIF 50 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). GIOTRIF 20 mg film-coated tablets: White to yellowish, round, biconvex and bevel-edged film-coated tablet debossed with the code “T20” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 30 mg film-coated tablets: Dark blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T30” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 40 mg film-coated tablets: Light blue, round, biconvex and bevel-edged film-coated tablet debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other. GIOTRIF 50 mg film-coated tablets: Dark blue, oval, biconvex film-coated tablet debossed with the code “T50” on one side and the Boehringer Ingelheim company logo on the other. |
GIOTRIF 20 mg film-coated tablets: One film-coated tablet contains 20 mg afatinib (as dimaleate).
Excipient with known effect: One film-coated tablet contains 118 mg lactose (as monohydrate).
Excipient with known effect: One film-coated tablet contains 176 mg lactose (as monohydrate).
Excipient with known effect: One film-coated tablet contains 235 mg lactose (as monohydrate).
Excipient with known effect: One film-coated tablet contains 294 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Afatinib |
Afatinib is a potent and selective, irreversible ErbB Family Blocker. Afatinib covalently binds to and irreversibly blocks signalling from all homo- and heterodimers formed by the ErbB family members EGFR (ErbB1), HER2 (ErbB2), ErbB3 and ErbB4. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: GIOTRIF 20 mg film-coated tablets: Hypromellose (E464) GIOTRIF 30, 40 and 50 mg film-coated tablets: Hypromellose (E464) |
PVC/PVDC perforated unit dose blister. Each blister is packed together with a desiccant sachet in a laminated aluminium pouch and contains 7 × 1 film-coated tablets. Pack sizes of 7 × 1, 14 × 1 or 28 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany
GIOTRIF 20 mg film-coated tablets:
EU/1/13/879/001
EU/1/13/879/002
EU/1/13/879/003
GIOTRIF 30 mg film-coated tablets:
EU/1/13/879/004
EU/1/13/879/005
EU/1/13/879/006
GIOTRIF 40 mg film-coated tablets:
EU/1/13/879/007
EU/1/13/879/008
EU/1/13/879/009
GIOTRIF 50 mg film-coated tablets:
EU/1/13/879/010
EU/1/13/879/011
EU/1/13/879/012
Date of first authorisation: 25 September 2013
Date of latest renewal: 16 May 2018
| Drug | Countries | |
|---|---|---|
| GIOTRIF | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom |
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