NEVANAC Eye drops, suspension Ref.[9458] Active ingredients: Nepafenac

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

NEVANAC 1 mg/ml eye drops, suspension.

Pharmaceutical Form

Eye drops, suspension.

Light yellow to light orange uniform suspension, pH 7.4 (approximately).

Qualitative and quantitative composition

1 ml of suspension contains 1 mg nepafenac.

Excipient with known effect: Each ml of suspension contains 0.05 mg of benzalkonium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nepafenac

Nepafenac is a non-steroidal anti-inflammatory and analgesic prodrug. After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac inhibits the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
List of Excipients

Mannitol (E421)
Carbomer
Sodium chloride
Tyloxapol
Disodium edetate
Benzalkonium chloride
Sodium hydroxide and/or hydrochloric acid (for pH adjustment)
Purified water

Pack sizes and marketing

5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml suspension.

Carton containing 1 bottle.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/07/433/001

Date of first authorisation: 11 December 2007
Date of latest renewal: 24 September 2012

Drugs

Drug Countries
NEVANAC Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa
 
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