Is Revefenacin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Revefenacin, including YUPELRI 175 mcg / 3 ml (175 µg, inhalation solution, SAR 71.50).

Is Revefenacin approved by the US FDA?

Drugs@FDA lists 1 application product line for Revefenacin, including YUPELRI (Prescription).

Are there safety signals or safety updates for Revefenacin?

US FDA: 1 entry (latest 2022-05-25).

Active substance

Revefenacin

SFDA 2
US FDA 1
US price lines 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
YUPELRI 175 mcg / 3 ml	175 µg	inhalation solution · Inhalation use	7 Single Dose Container	SAR 71.50	NCE · Prescription	Mylan Ireland Limited	Valid
YUPELRI 175 mcg / 3 ml	175 µg	inhalation solution · Inhalation use	30 Single Dose Container	SAR 306.50	NCE · Prescription	Mylan Ireland Limited	Valid

Indications — CHI Daman Drug Formulary

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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

Product	Strength	Form · route	Applicant	Status	First approved
YUPELRI	175MCG/3ML	solution · inhalation	MYLAN IRELAND LTD	Prescription	9 Nov 2018

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	YUPELRI 175 MCG/3 ML SOLUTION	$17.42713	per ML	23 Sep 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 25 May 2022 YUPELRI — safety-related labeling change
Labeling sections changed: Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for revefenacin →

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.