Komboglyze – Medicinal Product Register of Latvia

Saxagliptinum, Metformini hydrochloridum

Search by the name of the active substance

Medicinal product name	Komboglyze
Pharmaceutical form	Film-coated tablet
Strength	2.5 mg/850 mg
Information from the MAH on shortages	Not available predicted availability date: not notified
Legal status	Rx Prescription (Pr.) KZSL Next lowest cost medicine
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"
Substance	Class	Comment
Saxagliptinum	C	Suitable for older adults, with specific precautions. Reduce the dose already in moderately severe renal impairment. Do not use in hepatic impairment.
Metformini hydrochloridum		No data on active substance.

Medicinal products (1)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

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) predicted availability date: not notified	currently no information on availability from any wholesaler	N60 (2,5 mg/850 mg)	Al/Al blister	€ 54.43 KZSL*	EU/1/11/731/003	Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.

Registration information

Marketing authorisation No.	EU/1/11/731/003
Date of authorisation	Nov 24, 2011
Marketing authorisation holder, country	AstraZeneca AB, Sweden

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Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on Apr 19, 2024.