Is Albiglutide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Albiglutide.

Is Albiglutide approved by the US FDA?

Drugs@FDA lists 1 application product line for Albiglutide, including TANZEUM (Discontinued).

Is Albiglutide authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Albiglutide.

Are there safety signals or safety updates for Albiglutide?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2017-12-20).

Active substance

Albiglutide

SFDA 2
US FDA 1
EMA 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EPERZAN 30 mg Powder and Solvent For Solution For Injection	30 mg	Powder and solvent for solution for injection · Subcutaneous use	4 Pre-filled pen	SAR 415.90	Biological · Prescription	GLAXO EXPORT LIMITED	Withdrawn by MAH · Not Marketed
EPERZAN 50 mg Powder and Solvent For Solution For Injection	50 mg	Powder and solvent for solution for injection · Subcutaneous use	4 Pre-filled pen	SAR 415.90	Biological · Prescription	GLAXO EXPORT LIMITED	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
TANZEUM	30MG	injectable · injection	GLAXOSMITHKLINE LLC	Discontinued	15 Apr 2014

EMA European Union — centrally authorised medicines

Eperzan GlaxoSmithKline Trading Services Limited · Withdrawn · authorised 20 Mar 2014 · ATC A10BJ04

Therapeutic indication (EMA)

Eperzan is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycaemic control as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 4.4 and 5.1 for available data on different combinations).

Safety signals and safety-related labeling changes

US FDA 20 Dec 2017 TANZEUM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Apr 2017 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: Yes
EMA PRAC 1 Dec 2016 PRAC signal: Acute kidney injury
Action for MAH: update of the product information: No

All safety entries for albiglutide →

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.