Regulatory PathRegulatory requirements compared

Active substances

Empagliflozin + Linagliptin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
GLYXAMBI25,5 mg,mgFilm-coated tablet · Oral use30 BlisterSAR 226.05NCE · PrescriptionBOEHRINGER INGELHEIMValid
GLYXAMBI10,5 mg,mgFilm-coated tablet · Oral use30 BlisterSAR 226.05NCE · PrescriptionBOEHRINGER INGELHEIMValid
Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
GLYXAMBI10MG;5MG; 25MG;5MGtablet · oralBOEHRINGER INGELHEIMPrescription30 Jan 2015

EMA European Union — centrally authorised medicines

Glyxambi Boehringer Ingelheim International GmbH · Authorised · authorised 11 Nov 2016 · ATC A10BD19

Therapeutic indication (EMA)

Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control; when already being treated with the free combination of empagliflozin and linagliptin.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACGLYXAMBI 10 MG-5 MG TABLET$11.24368per EA23 Sep 2026
US NADACGLYXAMBI 25 MG-5 MG TABLET$11.19937per EA23 Sep 2026
NHS Drug TariffEmpagliflozin 10mg / Linagliptin 5mg tablets£55.8828 tablet1 Oct 2026
NHS Drug TariffEmpagliflozin 25mg / Linagliptin 5mg tablets£55.8828 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.