Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Komboglyze 2.5 mg/850 mg film-coated tablets.
Komboglyze 2.5 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Komboglyze 2.5 mg/850 mg film-coated tablets: Light brown to brown, biconvex, round, film-coated tablets, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink. Komboglyze 2.5 mg/1,000 mg film-coated tablets: Pale yellow to light yellow, biconvex, oval shaped, film-coated tablets, with “2.5/1000” printed on one side and “4247” printed on the other side, in blue ink. |
Komboglyze 2.5 mg/850 mg film-coated tablets: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 850 mg of metformin hydrochloride.
Komboglyze 2.5 mg/1,000 mg film-coated tablets: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Saxagliptin |
Combination of two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: saxagliptin, a dipeptidyl peptidase 4 (DPP4) inhibitor, and metformin hydrochloride, a member of the biguanide class. |
|
| Saxagliptin |
Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor. Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes. |
| List of Excipients |
|---|
|
Tablet core: Povidone K30 Film coating: Komboglyze 2.5 mg/850 mg film-coated tablets: Polyvinyl alcohol Komboglyze 2.5 mg/1,000 mg film-coated tablets: Polyvinyl alcohol Printing ink: Shellac |
Alu/Alu blister.
Pack sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters. Multipacks containing 112 (2 packs of 56) and 196 (7 packs of 28) film-coated tablets in non-perforated blisters.
60 × 1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Komboglyze 2.5 mg/850 mg film-coated tablets:
EU/1/11/731/001 28 film-coated tablets
EU/1/11/731/002 56 film-coated tablets
EU/1/11/731/003 60 film-coated tablets
EU/1/11/731/004 112 (2 packs of 56) film-coated tablets
EU/1/11/731/005 196 (7 packs of 28) film-coated tablets
EU/1/11/731/006 60x1 film-coated tablets
EU/1/11/731/013 14 film-coated tablets
Komboglyze 2.5 mg/1,000 mg film-coated tablets:
EU/1/11/731/007 28 film-coated tablets
EU/1/11/731/008 56 film-coated tablets
EU/1/11/731/009 60 film-coated tablets
EU/1/11/731/010 112 (2 packs of 56) film-coated tablets
EU/1/11/731/011 196 (7 packs of 28) film-coated tablets
EU/1/11/731/012 60x1 film-coated tablets
EU/1/11/731/014 14 film-coated tablets
Date of first authorisation: 24 November 2011
Date of latest renewal: 15 July 2016
| Drug | Countries | |
|---|---|---|
| KOMBOGLYZE | Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Poland, Romania, United Kingdom |
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