Is Nepafenac 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 Nepafenac, including NEVANAC EYE DROP (1 mg/ml, Eye drops, suspension, SAR 23.90).

Is Nepafenac approved by the US FDA?

Drugs@FDA lists 2 application product lines for Nepafenac, including NEVANAC (Prescription); ILEVRO (Prescription).

Is Nepafenac authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Nepafenac: Nevanac.

Are there safety signals or safety updates for Nepafenac?

US FDA: 1 entry (latest 2017-12-15).

Active substance

Nepafenac

SFDA 1
US FDA 2
EMA 1
Health Canada 2
US price lines 2
NHS prices 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
NEVANAC EYE DROP	1 mg/ml	Eye drops, suspension · Ocular use	1 Dropper Container	SAR 23.90	NCE · Prescription	NOVARTIS PHARMA AG	Valid

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); CYSTOID MACULAR EDEMA; NON-INFECTIOUS UVEITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
NEVANAC	0.1%	suspension/drops · ophthalmic	HARROW EYE	Prescription	19 Aug 2005
ILEVRO	0.3%	suspension/drops · ophthalmic	HARROW EYE	Prescription	16 Oct 2012

EMA European Union — centrally authorised medicines

Nevanac Novartis Europharm Limited · Authorised · authorised 11 Dec 2007 · ATC S01BC10

Therapeutic indication (EMA)

Nevanac is indicated for: prevention and treatment of postoperative pain and inflammation associated with cataract surgery; reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ILEVRO	02411393	0.3 % / W/V	SUSPENSION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
NEVANAC	02308983	0.1 % / W/V	SUSPENSION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ILEVRO 0.3% OPHTH DROPS	$121.14312	per ML	23 Sep 2026
US NADAC	NEVANAC 0.1% EYE DROP	$104.7075	per ML	23 Sep 2026
NHS Drug Tariff	Nepafenac 1mg/ml eye drops	£14.92	5 ml	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 15 Dec 2017 NEVANAC — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for nepafenac →

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.