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GIOTRIF Film-coated tablets (2020)

Active ingredients: Afatinib

Product Name and Form

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.

Qualitative and Quantitative Composition

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).

  • GIOTRIF 30 mg film-coated tablets:* One film-coated tablet contains 30 mg afatinib (as dimaleate).

Excipient with known effect: One film-coated tablet contains 176 mg lactose (as monohydrate).

  • GIOTRIF 40 mg film-coated tablets:* One film-coated tablet contains 40 mg afatinib (as dimaleate).

Excipient with known effect: One film-coated tablet contains 235 mg lactose (as monohydrate).

  • GIOTRIF 50 mg film-coated tablets:* One film-coated tablet contains 50 mg afatinib (as dimaleate).

Excipient with known effect: One film-coated tablet contains 294 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Chemical substance
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
Cellulose, microcrystalline (E460)
Silica, colloidal anhydrous (E551)
Crospovidone (type A)
Magnesium stearate (E470b)

Film-coating:

GIOTRIF 20 mg film-coated tablets:

Hypromellose (E464)
Macrogol 400
Titanium dioxide (E171)
Talc (E553b)
Polysorbate 80 (E433)

GIOTRIF 30, 40 and 50 mg film-coated tablets:

Hypromellose (E464)
Macrogol 400
Titanium dioxide (E171)
Talc (E553b)
Polysorbate 80 (E433)
Indigo carmine aluminium lake (E132)

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Germany

Date of first authorisation: 25 September 2013

Date of latest renewal: 16 May 2018

Marketing authorization number:

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