Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Glyxambi 10 mg/5 mg film-coated tablets.
Glyxambi 25 mg/5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Glyxambi 10 mg/5 mg film-coated tablets: Pale yellow, arc triangular, flat faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “10/5” (tablet dimensions: 8 mm each side). Glyxambi 25 mg/5 mg film-coated tablets: Pale pink, arc triangular, flat faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “25/5” (tablet dimensions: 8 mm each side). |
Glyxambi 10 mg/5 mg film-coated tablets: Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Glyxambi 25 mg/5 mg film-coated tablets: Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Empagliflozin |
Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of sodium-glucose co-transporter 2 (SGLT2). Empagliflozin improves glycaemic control in patients with type 2 diabetes by reducing renal glucose reabsorption. |
|
| 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. |
|
| Linagliptin and Empagliflozin |
Antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes. Linagliptin is an inhibitor of DPP-4 an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide). Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of SGLT2. |
| List of Excipients |
|---|
Glyxambi 10 mg/5 mg film-coated tabletsTablet core: Mannitol (E421) Film coating: Hypromellose 2910 Glyxambi 25 mg/5 mg film-coated tabletsTablet core: Mannitol (E421) Film coating: Hypromellose 2910 |
PVC/PVDC/aluminium perforated unit dose blisters.
Pack sizes of 7 × 1, 10 × 1, 14 × 1, 28 × 1, 30 × 1, 60 × 1, 70 × 1, 90 × 1 and 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Boehringer Ingelheim International GmbH, Binger Str. 173, 55216 Ingelheim am Rhein, Germany
Glyxambi 10 mg/5 mg film-coated tablets:
EU/1/16/1146/001 (7 × 1 film-coated tablets)
EU/1/16/1146/002 (10 × 1 film-coated tablets)
EU/1/16/1146/003 (14 × 1 film-coated tablets)
EU/1/16/1146/004 (28 × 1 film-coated tablets)
EU/1/16/1146/005 (30 × 1 film-coated tablets)
EU/1/16/1146/006 (60 × 1 film-coated tablets)
EU/1/16/1146/007 (70 × 1 film-coated tablets)
EU/1/16/1146/008 (90 × 1 film-coated tablets)
EU/1/16/1146/009 (100 × 1 film-coated tablets)
Glyxambi 25 mg/5 mg film-coated tablets:
EU/1/16/1146/010 (7 × 1 film-coated tablets)
EU/1/16/1146/011 (10 × 1 film-coated tablets)
EU/1/16/1146/012 (14 × 1 film-coated tablets)
EU/1/16/1146/013 (28 × 1 film-coated tablets)
EU/1/16/1146/014 (30 × 1 film-coated tablets)
EU/1/16/1146/015 (60 × 1 film-coated tablets)
EU/1/16/1146/016 (70 × 1 film-coated tablets)
EU/1/16/1146/017 (90 × 1 film-coated tablets)
EU/1/16/1146/018 (100 × 1 film-coated tablets)
Date of first authorisation: 11 November 2016
Date of latest renewal: 16 July 2021
| Drug | Countries | |
|---|---|---|
| GLYXAMBI | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States |
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