Is Vildagliptin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 25 valid registrations of Vildagliptin, including Diaglipt (50 mg, Tablet, SAR 62.05); GALVUS 50MG TABLETS (50 mg, Tablet, SAR 112.30); GAVILDA 50MG TABLET 28S (50 mg, Tablet, SAR 33.25); GAVILDA 50MG TABLET 56S (50 mg, Tablet, SAR 66.50); GLEPTAL 50MG TABLET (50 mg, Tablet, SAR 33.25).

Is Vildagliptin authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Vildagliptin: Galvus, Jalra, Xiliarx.

Are there safety signals or safety updates for Vildagliptin?

EMA PRAC: 14 entries (latest 2021-12-02).

Active substance

Vildagliptin

SFDA 25
EMA 3
NHS prices 1
Safety 14

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Diaglipt	50 mg	Tablet · Oral use	56 Blister	SAR 62.05	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
GALVUS 50MG TABLETS	50 mg	Tablet · Oral use	56 Blister	SAR 112.30	NCE · Prescription	NOVARTIS	Valid
GALVUS 50MG TABLETS	50 mg	Tablet · Oral use	28 Blister	SAR 56.10	NCE · Prescription	NOVARTIS	Valid
GAVILDA 50MG TABLET 28S	50 mg	Tablet · Oral use	28 Blister	SAR 33.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
GAVILDA 50MG TABLET 56S	50 mg	Tablet · Oral use	56 Blister	SAR 66.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
GLEPTAL 50MG TABLET	50 mg	Tablet · Oral use	30 Blister	SAR 33.25	Generic · Prescription	Al-Taqaddom pharmaceutical Industries	Valid
Geuvid	50 mg	Tablet · Oral use	60 Blister	SAR 66.50	Generic · Prescription	Saudi Amarox	Valid
Geuvid	50 mg	Tablet · Oral use	30 Blister	SAR 33.25	Generic · Prescription	Saudi Amarox	Valid
Gleptal	50 mg	Tablet · Oral use	60 Blister	SAR 66.50	Generic · Prescription	Al-Taqaddom pharmaceutical Industries	Valid
Gliptus	50 mg	Tablet · Oral use	60 Blister	SAR 66.50	Generic · Prescription	Eva pharma for Industry	Valid
Iylus	50 mg	Tablet · Oral use	30 Blister	SAR 33.25	Generic · Prescription	Savvy Pharma	Valid
JALRA 50 mg tablet	50 mg	Tablet · Oral use	28 Blister	SAR 45.60	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
JALRA 50 mg tablet	50 mg	Tablet · Oral use	56 Blister	SAR 91.20	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
VALDATIN 50MG TABLET	50 mg	Tablet · Oral use	28 Blister	SAR 33.25	Generic · Prescription	SPIMACO ADDWAEIH	Valid
VALDATIN 50MG TABLET	50 mg	Tablet · Oral use	56 Blister	SAR 66.50	Generic · Prescription	SPIMACO ADDWAEIH	Valid
VILDATIN 50 mg Tablet	50 mg	Tablet · Oral use	28 Blister	SAR 36.95	Generic · Prescription	Med City Pharma	Valid
VILDATIN 50 mg Tablet	50 mg	Tablet · Oral use	60 Blister	SAR 79.15	Generic · Prescription	Med City Pharma	Valid
VILTIN 50 MG TABLET	50 mg	Tablet · Oral use	60 Blister	SAR 66.50	Generic · Prescription	Pharma International Co.	Valid
VILTIN 50 mg Tablet	50 mg	Tablet · Oral use	28 Blister	SAR 31.05	Generic · Prescription	Pharma International Co.	Valid
Vdia	50 mg	Tablet · Oral use	28 Blister	SAR 33.25	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Vdia	50 mg	Tablet · Oral use	56 Blister	SAR 66.50	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Vildus	50 mg	Tablet · Oral use	30 Blister	SAR 33.25	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Vildus	50 mg	Tablet · Oral use	60 Blister	SAR 66.50	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Vtreat	50 mg	Tablet · Oral use	56 Blister	SAR 62.05	Generic · Prescription	Spectro Pharma	Valid
Vtreat	50 mg	Tablet · Oral use	28 Blister	SAR 31.05	Generic · Prescription	Spectro Pharma	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

EMA European Union — centrally authorised medicines

Galvus Novartis Europharm Limited · Authorised · authorised 25 Sep 2007 · ATC A10BH02

Therapeutic indication (EMA)

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: as monotherapy in patients in whom metformin is inappropriate due to contraindications or intolerance. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control

Jalra Novartis Europharm Limited · Authorised · authorised 19 Nov 2008 · ATC A10BH02

Therapeutic indication (EMA)

Xiliarx Novartis Europharm Limited · Authorised · authorised 19 Nov 2008 · ATC A10BH02

Therapeutic indication (EMA)

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Vildagliptin 50mg tablets	£5.77	56 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

EMA PRAC 2 Dec 2021 PRAC signal: Cutaneous vasculitis
Action for MAH: update of the product information: No
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 1 Dec 2016 PRAC signal: Pemphigoid
Action for MAH: update of the product information: Yes
EMA PRAC 8 Jul 2016 PRAC signal: Pemphigoid
Action for MAH: update of the product information: No
EMA PRAC 10 Apr 2015 PRAC signal: Intestinal obstruction
Action for MAH: update of the product information: No
EMA PRAC 4 Dec 2014 PRAC signal: Myalgia [previously: rhabdomyolysis]
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2014 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No
EMA PRAC 6 Nov 2014 PRAC signal: Renal failure
Action for MAH: update of the product information: No
EMA PRAC 13 Jun 2014 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: Yes
EMA PRAC 13 Jun 2014 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: Yes
EMA PRAC 6 Feb 2014 PRAC signal: Interstitial lung disease
Action for MAH: update of the product information: No

All safety entries for vildagliptin →

Combinations containing Vildagliptin

Metformin + vildagliptin

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.