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MedsAcross

Molecule

Nepafenac

Anti-Inflammatory Agents
Available on requestOphthalmology
Presentations
2
Brands
2
Manufacturers
1
Available from stock
0

Nepafenac is a nonsteroidal anti-inflammatory drug indicated for the treatment of pain and inflammation associated with cataract surgery. It is available as ophthalmic suspension. MedsAcross supplies Nepafenac for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Anti-Inflammatory Agents, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors
ATC classification
S01BC10 Nepafenac · Eye medicines, subgroup S01B, subgroup S01BC
US FDA first approval
19 August 2005
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Ophthalmic suspension
Identifiers
UNII 0J9L7J6V8CRxCUI 298665CAS 78281-72-8DrugBank DB06802Q684379

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

NEVANAC ® 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery. NEVANAC is a nonsteroidal, anti-inflammatory prodrug indicated for the treatment of pain and inflammation associated with cataract surgery.

Source: US FDA prescribing information

How it works

After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, an NSAID. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

Source: US FDA prescribing information

Dosing overview

One drop of NEVANAC should be applied to the affected eye three times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period.

Source: US FDA prescribing information

Contraindications

NEVANAC 0.1% is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDs). Hypersensitivity to any of the ingredients in the formula or to other non-steroidal anti-inflammatory drugs (NSAIDS).

Source: US FDA prescribing information

Warnings and precautions

Increased bleeding time due to interference with thrombocyte aggregation. Delayed Healing. Corneal effects, including keratitis Increased Bleeding Time With some NSAIDs, including NEVANAC 0.1%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery. It is recommended that NEVANAC 0.1% be used with caution in patients with known bleeding tendencies, or who are receiving other medications, which may prolong bleeding time. Delayed Healing Topical NSAIDs, including NEVANAC 0.1%, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in greater detail in other sections of labeling: Increased Bleeding Time Delayed Healing Corneal Effects Most common adverse reactions (5% to 10%) are capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure (IOP), and sticky sensation.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Nepafenac, sorted by availability.

MedicineManufacturerRegisterAvailability
Ilevro 3 mg/mL ophthalmic suspensionOphthalmicHarrow EyeUS FDAAvailable on request
Nevanac 1 mg/mL ophthalmic suspensionOphthalmicHarrow EyeUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 19 August 2005Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Nepafenac available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Nepafenac and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Nepafenac have?

The catalogue lists 2 brand names for Nepafenac, including Ilevro, Nevanac.

Is Nepafenac approved by the US FDA?

Yes. The US FDA first approved Nepafenac on 19 August 2005, according to Drugs@FDA.

Is Nepafenac authorised in the European Union?

Yes. Nepafenac has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Nepafenac need cold chain shipping?

No listed presentation of Nepafenac is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Nepafenac in?

Nepafenac is classified under ATC code S01BC10 (Nepafenac).

References

  1. NEVANAC prescribing information (Harrow Eye). U.S. National Library of Medicine, DailyMed. Retrieved 5 November 2024
  2. Nevanac: European public assessment report (EPAR). European Medicines Agency. Retrieved 23 January 2026

Request Nepafenac for export supply

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