MedPath

Nepafenac

Generic Name
Nepafenac
Brand Names
Ilevro, Nevanac
Drug Type
Small Molecule
Chemical Formula
C15H14N2O2
CAS Number
78281-72-8
Unique Ingredient Identifier
0J9L7J6V8C

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
2022/04/18
Phase 4
Recruiting
Oslo University Hospital
2021/10/08
Phase 4
Recruiting
Oslo University Hospital
2021/04/14
Phase 2
UNKNOWN
2019/04/17
Phase 4
UNKNOWN
2019/03/22
Phase 4
Completed
2019/02/22
Phase 2
UNKNOWN
2018/07/24
Phase 3
Completed
2018/04/17
Phase 3
Completed
2018/01/23
Not Applicable
Completed
University Hospital of Patras
2017/01/20
Not Applicable
Completed
Intuor Technologies, Inc.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Novartis Pharmaceuticals Corporation
0078-0778
OPHTHALMIC
1 mg in 1 mL
9/6/2021
Novartis Pharmaceuticals Corporation
0078-0743
OPHTHALMIC
3 mg in 1 mL
3/17/2020
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
Authorised
12/11/2007

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Nevanac® Eye Drops Suspension 1 mg/ml
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

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
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
07433001IP1
COLIRIO EN SUSPENSIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
NEVANAC 1 mg/ml COLIRIO EN SUSPENSION
07433001
COLIRIO EN SUSPENSIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
NEVANAC 3MG/ML COLIRIO EN SUSPENSION
107433003IP1
COLIRIO EN SUSPENSIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
NEVANAC 3mg/ml colirio en suspension
107433003
COLIRIO EN SUSPENSIÓN
Medicamento Sujeto A Prescripción Médica
Commercialized
NEVANAC 3 MG/ML COLIRIO EN SUSPENSION
07433002IP
COLIRIO EN SUSPENSIÓN
Medicamento Sujeto A Prescripción Médica
Not Commercialized
NEVANAC 3MG/ML COLIRIO EN SUSPENSION
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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