Komboglyze – Medicinal Product Register of Latvia

Saxagliptinum, Metformini hydrochloridum

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Medicinal product name

Komboglyze

Pharmaceutical form

Film-coated tablet

Strength

2.5 mg/1000 mg

Information from the MAH on shortages

Not available
predicted availability date: not notified

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
EU/1/11/731/009 KZSL	N60	Is available

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
Is available (according to the information provided by wholesalers) (83 containers) predicted availability date: not notified	Tamro, Magnum Medical, Euroaptieka	N60 (2,5 mg/1000 mg)	Al/Al blister	€ 54.43 KZSL*	EU/1/11/731/009	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/1/11/731/009
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 24, 2024.