Active substance
Ertugliflozin
- SFDA 2
- US FDA 4
- NHS prices 2
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Steglatro | 15 mg | Film-coated tablet · Oral use | 30 Blister | SAR 159.00 | NCE · Prescription | Merck Sharp & Dohme B.V | Withdrawn by MAH · Not Marketed |
| Steglatro | 5 mg | Film-coated tablet · Oral use | 30 Blister | SAR 159.00 | NCE · Prescription | Merck Sharp & Dohme B.V | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| STEGLATRO | 5MG; 15MG | tablet · oral | MSD SUB MERCK | Prescription | 19 Dec 2017 |
| ERTUGLIFLOZIN | 5MG; 15MG | tablet · oral | AUROBINDO PHARMA LTD | Discontinued | 13 Jul 2023 |
| ERTUGLIFLOZIN | 5MG; 15MG | tablet · oral | HETERO LABS LTD V | Discontinued | 17 Sep 2024 |
| ERTUGLIFLOZIN | 5MG; 15MG | tablet · oral | HIKMA PHARMS | Discontinued | 21 Jan 2025 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| NHS Drug Tariff | Ertugliflozin 15mg tablets | £29.40 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Ertugliflozin 5mg tablets | £29.40 | 28 tablet | 1 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.
Safety signals and safety-related labeling changes
- US FDA 11 Aug 2026 SEGLUROMET — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 3 Jun 2026 STEGLATRO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 3 Jun 2026 STEGLUJAN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 13 Mar 2025 PRAC signal: Sarcopenia
Action for MAH: update of the product information: No - EMA PRAC 5 Sep 2024 PRAC signal: Sarcopenia
Action for MAH: update of the product information: No - EMA PRAC 15 Mar 2019 PRAC signal: New information on the known association between sodium-glucose co-transporter 2 (SGLT2) inhibitors and diabetic ketoacidosis (DKA) in surgical patients
Action for MAH: update of the product information: No - EMA PRAC 29 Nov 2018 PRAC signal: Fournier’s gangrene
Action for MAH: update of the product information: Yes - EMA PRAC 4 Oct 2018 PRAC signal: Fournier’s gangrene
Action for MAH: update of the product information: No
Combinations containing Ertugliflozin
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.