Nepafenac

Overview

Nepafenac is a non-steroidal anti-inflammatory prodrug (NSAID) usually sold as a prescription eye drop. It is used to treat pain and inflammation associated with cataract surgery.

Indication

For the treatment of pain and inflammation associated with cataract surgery.

Associated Conditions

Inflammation
Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)	2022/04/18	NCT05331690	Phase 4	Recruiting	Oslo University Hospital
DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)	2021/10/08	NCT05072262	Phase 4	Recruiting	Oslo University Hospital
CHED - Congenital Hereditary Endothelial Dystrophy: New Paradigm Shift in Therapy Using Topical Eye Drops	2021/04/14	NCT04843839	Phase 2	UNKNOWN	L.V. Prasad Eye Institute
Post Intravitreal Injection Topical NSAID vs. Patching	2019/04/17	NCT03918590	Phase 4	UNKNOWN	The New York Eye & Ear Infirmary
Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial	2019/03/22	NCT03886779	Phase 4	Completed	Silverstein Eye Centers
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery	2019/02/22	NCT03851172	Phase 2	UNKNOWN	Assiut University
PGE2 Levels in Patient Treated With NSAIDs	2018/07/24	NCT03597867	Phase 3	Completed	University of Trieste
Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension	2018/04/17	NCT03499873	Phase 3	Completed	Actavis Inc.
Comparison of the Efficacy of Nepafenac 0.1% and Nepafenac 0.3 % on Pain Associated With Intravitreal Injections	2018/01/23	NCT03406689	Not Applicable	Completed	University Hospital of Patras
Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo	2017/01/20	NCT03025945	Not Applicable	Completed	Intuor Technologies, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
NEVANAC	Novartis Pharmaceuticals Corporation	0078-0778	OPHTHALMIC	1 mg in 1 mL	9/6/2021
ILEVRO	Novartis Pharmaceuticals Corporation	0078-0743	OPHTHALMIC	3 mg in 1 mL	3/17/2020
Nevanac	Physicians Total Care, Inc.	54868-6302	OPHTHALMIC	1 mg in 1 mL	8/31/2011

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Nevanac	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	12/11/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Nevanac® Eye Drops Suspension 1 mg/ml	S.A. Alcon-Couvreur N.V.	SIN13759P	SUSPENSION, STERILE	1.0 mg/ml	1/28/2010

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ILEVRO nepafenac 0.3% eye drops, suspension, oval bottle	309880	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	8/30/2019
ILEVRO nepafenac 0.3% eye drops, suspension, bottle	230200	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	11/4/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NEVANAC	novartis pharmaceuticals canada inc	02308983	Suspension - Ophthalmic	0.1 % / W/V	8/21/2008
ILEVRO	novartis pharmaceuticals canada inc	02411393	Suspension - Ophthalmic	0.3 % / W/V	6/1/2014

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
NEVANAC 3mg/ml colirio en suspension	Novartis Europharm Limited	107433002	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NEVANAC 1mg/ml colirio en suspension	Alcon Laboratories Ltd (Uk)	07433001IP	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
NEVANAC 1 MG/ML COLIRIO EN SUSPENSION	Novartis Europharm Limited	07433001IP1	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NEVANAC 1 mg/ml COLIRIO EN SUSPENSION	Novartis Europharm Limited	07433001	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
NEVANAC 3MG/ML COLIRIO EN SUSPENSION	Novartis Europharm Limited	107433003IP1	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
NEVANAC 3mg/ml colirio en suspension	Novartis Europharm Limited	107433003	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
NEVANAC 3 MG/ML COLIRIO EN SUSPENSION	Novartis Europharm Limited	07433002IP	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
NEVANAC 3MG/ML COLIRIO EN SUSPENSION	Novartis Europharm Limited	107433003IP	COLIRIO EN SUSPENSIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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