KOMBOGLYZE Film-coated tablet Ref.[10497] Active ingredients: Metformin Metformin and Saxagliptin Saxagliptin

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

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.

Qualitative and quantitative composition

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
Magnesium stearate

Film coating:

Komboglyze 2.5 mg/850 mg film-coated tablets:

Polyvinyl alcohol
Macrogol 3350
Titanium dioxide (E171)
Talc (E553b)
Iron oxide red (E172)
Iron oxide yellow (E172)

Komboglyze 2.5 mg/1,000 mg film-coated tablets:

Polyvinyl alcohol
Macrogol 3350
Titanium dioxide (E171)
Talc (E553b)
Iron oxide yellow (E172)

Printing ink:

Shellac
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

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.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

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

Drugs

Drug Countries
KOMBOGLYZE Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Ireland, Lithuania, Poland, Romania, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.