Is Linagliptin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Linagliptin, including Dixee (5 mg, Film-coated tablet, SAR 68.05); Glynta (5 mg, Film-coated tablet, SAR 68.05); Jentarole (5 mg, Film-coated tablet, SAR 68.05); Lavinda (5 mg, Film-coated tablet, SAR 73.70); Lijen (5 mg, Film-coated tablet, SAR 68.05).

Is Linagliptin approved by the US FDA?

Drugs@FDA lists 9 application product lines for Linagliptin, including TRADJENTA (Prescription); LINAGLIPTIN (Prescription); LINAGLIPTIN (Prescription); LINAGLIPTIN (Prescription); LINAGLIPTIN (Prescription).

Is Linagliptin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Linagliptin: Trajenta.

Are there safety signals or safety updates for Linagliptin?

EMA PRAC: 6 entries; US FDA: 5 entries (latest 2026-08-11).

Active substance

Linagliptin

SFDA 11
US FDA 9
EMA 1
Health Canada 1
US price lines 1
NHS prices 1
Safety 11

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Dixee	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Glynta	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Jentarole	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Lavinda	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 73.70	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Lijen	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	Med City Pharma	Valid
Linajent	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Lintra	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 94.80	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Liptyn	5 mg	Tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	Saudi Amarox	Valid
Lynxelin	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
TRAJENTA 5MG FILM COATED TABLET	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 99.80	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
Tralix	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 68.05	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

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

Product	Strength	Form · route	Applicant	Status	First approved
TRADJENTA	5MG	tablet · oral	BOEHRINGER INGELHEIM	Prescription	2 May 2011
LINAGLIPTIN	5MG	tablet · oral	SUNSHINE	Prescription	31 Aug 2021
LINAGLIPTIN	5MG	tablet · oral	ZYDUS PHARMS	Prescription	30 Mar 2023
LINAGLIPTIN	5MG	tablet · oral	INVAGEN PHARMS	Prescription	3 Sep 2024
LINAGLIPTIN	5MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	3 Nov 2025
LINAGLIPTIN	5MG	tablet · oral	DR REDDYS	Prescription	3 Nov 2025
LINAGLIPTIN	5MG	tablet · oral	MYLAN	Prescription	3 Nov 2025
LINAGLIPTIN	5MG	tablet · oral	MSN	Prescription	3 Nov 2025
LINAGLIPTIN	5MG	tablet · oral	TEVA PHARMS USA	Prescription	27 May 2026

EMA European Union — centrally authorised medicines

Trajenta Boehringer Ingelheim International GmbH · Authorised · authorised 23 Aug 2011 · ATC A10BH05

Therapeutic indication (EMA)

Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults: as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. as combination therapy in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TRAJENTA	02370921	5 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRADJENTA 5 MG TABLET	$16.79819	per EA	23 Sep 2026
NHS Drug Tariff	Linagliptin 5mg tablets	£33.26	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 JENTADUETO — 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 11 Aug 2026 JENTADUETO XR — 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 11 Aug 2026 TRIJARDY XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Oct 2025 GLYXAMBI — 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 20 Jun 2023 TRADJENTA — 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 14 May 2020 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: No
EMA PRAC 16 Jan 2020 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: No
EMA PRAC 14 Jun 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 17 Jan 2019 PRAC signal: Increased risk of cholangiocarcinoma in adults with type 2 diabetes
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2016 PRAC signal: Arthralgia
Action for MAH: update of the product information: No
EMA PRAC 8 Oct 2015 PRAC signal: Arthralgia
Action for MAH: update of the product information: No

All safety entries for linagliptin →

Combinations containing Linagliptin

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.