Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany
Trajenta 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). 8 mm diameter round, light red film-coated tablet debossed with “D5” on one side and the Boehringer Ingelheim logo on the other. |
Each tablet contains 5 mg of linagliptin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Linagliptin |
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide). These hormones are rapidly degraded by the enzyme DPP-4. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. |
| List of Excipients |
|---|
|
Tablet core: Mannitol Film coating: Hypromellose |
Perforated alu/alu unit dose blisters in cartons containing 10 × 1, 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1, 100 × 1 and 120 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, D-55216 Ingelheim am Rhein, Germany
EU/1/11/707/001 (10 × 1 tablets)
EU/1/11/707/002 (14 × 1 tablets)
EU/1/11/707/003 (28 × 1 tablets)
EU/1/11/707/004 (30 × 1 tablets)
EU/1/11/707/005 (56 × 1 tablets)
EU/1/11/707/006 (60 × 1 tablets)
EU/1/11/707/007 (84 × 1 tablets)
EU/1/11/707/008 (90 × 1 tablets)
EU/1/11/707/009 (98 × 1 tablets)
EU/1/11/707/010 (100 × 1 tablets)
EU/1/11/707/011 (120 × 1 tablets)
Date of first authorisation: 24 August 2011
Date of latest renewal: 22 March 2016
| Drug | Countries | |
|---|---|---|
| TRAJENTA | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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