Medicinal product name Komboglyze
Pharmaceutical form Film-coated tablet
Strength 2.5 mg/850 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Summary of product characteristics, package leaflet and labeling text  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code A10BD10 Drugs used in diabetes

Important notice

Additional information regarding the use for persons aged 75+

If used as "DRUGS USED IN DIABETES"
SubstanceClassComment
Saxagliptinum No data on active substance.
Metformini hydrochloridumCSuitable for older adults, with specific precautions. Reduce the dose already in mild renal impairment. Do not use in severe renal impairment or tissue hypoxia. May reduce the absorption of vitamin B12. Consider risk of lactic acidosis. The drug should be paused during fever, gastroenteritis or dehydration, and before surgery or imaging with a contrast agent.

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N112
(2,5 mg/850 mg)
Al/Al blister    EU/1/11/731/004  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/11/731/004
Date of authorisation Nov 24, 2011
Marketing authorisation holder, country AstraZeneca AB, Sweden