Is Teduglutide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Teduglutide, including Revestive (5 mg, Powder and solvent for solution for injection, SAR 77665.85).

Is Teduglutide approved by the US FDA?

Drugs@FDA lists 1 application product line for Teduglutide, including GATTEX KIT (Prescription).

Is Teduglutide authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Teduglutide: Revestive, Teduglutide Viatris.

Active substance

Teduglutide

SFDA 1
US FDA 1
EMA 2
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Revestive	5 mg	Powder and solvent for solution for injection · Subcutaneous use	28 Vial	SAR 77665.85	Biological · Prescription	Takeda Pharmaceuticals International AG	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
GATTEX KIT	5MG/VIAL	powder · subcutaneous	TAKEDA PHARMS USA	Prescription	21 Dec 2012

EMA European Union — centrally authorised medicines

Revestive Takeda Pharmaceuticals International AG Ireland · Authorised · authorised 30 Aug 2012 · ATC A16AX08

Therapeutic indication (EMA)

Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery. Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.

Teduglutide Viatris Viatris Limited · Authorised · authorised 8 Jan 2026 · ATC A16AX08

Therapeutic indication (EMA)

Teduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REVESTIVE	02445727	5 MG / VIAL	KIT; POWDER FOR SOLUTION · SUBCUTANEOUS	TAKEDA CANADA INC

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.