Regulatory PathRegulatory requirements compared

Active substance

Ertugliflozin l pyroglutamic acid

Open in the medicines table

EMA European Union — centrally authorised medicines

Steglatro Merck Sharp & Dohme B.V. · Authorised · authorised 21 Mar 2018 · ATC A10BK04

Therapeutic indication (EMA)

Steglatro is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications. in addition to other medicinal products for the treatment of diabetes.

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
STEGLATRO 15 MG FILM-COATED TABLETSPLGB 53095/0065MERCK SHARP & DOHME (UK) LIMITEDPOM
STEGLATRO 5 MG FILM-COATED TABLETSPLGB 53095/0064MERCK SHARP & DOHME (UK) LIMITEDPOM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.