Nevanac

nepafenac

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This is a summary of the European public assessment report (EPAR) for Nevanac. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nevanac.

What is Nevanac?

Nevanac is an eye drop suspension that contains the active substance nepafenac (1 and 3 mg/ml).

What is Nevanac used for?

Nevanac is used in adults to prevent and treat the pain and inflammation that can occur after an operation to remove a cataract from the eye.

Nevanac is also used to reduce the risk of macular oedema (swelling in the macula, the central part of the retina at the back of the eye) that can occur after cataract surgery in adult diabetes patients.

The medicine can only be obtained with a prescription.

How is Nevanac used?

One drop of Nevanac is given into the affected eye(s), either three times a day with the 1 mg/ml strength, or once a day if using the 3 mg/ml strength. Treatment should begin one day before the cataract operation. Treatment is continued after the operation for 2 to 3 weeks when used to prevent pain and inflammation, or up to 60 days when used to reduce the risk of macular oedema. An extra drop should be given 30 to 120 minutes before the operation begins. If other eye medicines are also being used, there should be a gap of at least five minutes between using each medicine.

How does Nevanac work?

The active substance in Nevanac, nepafenac, is a ‘prodrug’ of amfenac. This means that it is converted into amfenac in the eye. Amfenac is a non‑steroidal anti‑inflammatory drug (NSAID). It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins in the eye, Nevanac can reduce complications caused by eye surgery, such as inflammation, pain and swelling.

How has Nevanac been studied?

For the prevention and treatment of pain and inflammation, Nevanac 1 mg/ml has been studied in four main studies involving a total of 1,201 patients undergoing cataract surgery. One study compared Nevanac 1 mg/ml used once, twice or three times a day with placebo (dummy eye drops) in 220 patients. Another three studies, in a total of 981 patients, compared Nevanac used three times a day, either with placebo, with ketorolac eye drops (another NSAID) or with both placebo and ketorolac. The main measure of effectiveness was either the proportion of patients in whom treatment had been successful (with no or few signs of inflammation in the eye), or the proportion of patients whose treatment had failed (with signs of moderate or severe inflammation in the eye). These were measured two weeks after surgery.

The company also carried out studies to show that Nevanac 3 mg/ml given once a day was more effective than placebo and had the same effect in preventing and treating pain and inflammation as Nevanac 1 mg/ml given three times a day.

For reducing the risk of macular oedema, Nevanac has been compared with placebo in three main studies involving 1483 diabetes patients with retinopathy (damage to the retina) undergoing cataract surgery. The first main study used Nevanac 1 mg/ml whereas the other 2 main studies used Nevanac 3 mg/ml. The main measure of effectiveness was the number of patients who developed macular oedema within 90 days of surgery.

What benefit has Nevanac shown during the studies?

Nevanac was more effective than placebo and as effective as ketorolac in reducing signs of inflammation. In the study comparing different numbers of drops daily, the patients using Nevanac 1 mg/ml three times a day had the lowest failure rate. When Nevanac was compared with placebo, around 70% of the patients using Nevanac had no signs of inflammation after two weeks, compared with 17% to 59% of those using placebo. In the study comparing Nevanac with ketorolac, around 65% of both groups of patients showed no or few signs of inflammation.

In diabetes patients, Nevanac was more effective than placebo in reducing the risk of macular oedema. In the first study, 3.2% of patients taking Nevanac 1 mg/ml developed macular oedema (4 out of 125), compared with 16.7% of patients taking placebo (21 out of 126). In the second and third study, 2.3% and 5.9% of patients taking Nevanac 3 mg/ml developed macular oedema, respectively, compared with between 17.3% and 14.3% of patients taking placebo.

What is the risk associated with Nevanac?

The most common side effects with Nevanac (seen in up to 1 in 100 patients) are inflammation of the surface of the eye, defects in the cornea, the sensation of a foreign body in the eye, and crust forming at edge on the eyelids. For the full list of all side effects reported with Nevanac, see the package leaflet.

Nevanac must not be used in people who are hypersensitive (allergic) to nepafenac, to any of the other ingredients or to other NSAIDs. Like other NSAIDs, Nevanac must not be used in patients who have previously had an attack of asthma, hives or inflammation of the nasal passages when they take aspirin or other NSAIDs. Nevanac contains benzalkonium chloride, which is known to discolour soft contact lenses. Additionally, contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses during treatment with Nevanac.

Why has Nevanac been approved?

The CHMP decided that Nevanac’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Nevanac?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nevanac have also been included in the summary of product characteristics and the package leaflet.

Other information about Nevanac

The European Commission granted a marketing authorisation valid throughout the European Union for Nevanac on 11 December 2007.

For more information about treatment with Nevanac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Nevanac : EPAR - Summary for the public BG = bălgarski 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public ES = español 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public CS = čeština 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public DA = dansk 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public DE = Deutsch 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public ET = eesti keel 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public EL = elliniká 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public EN = English 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public FR = français 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public IT = italiano 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public LV = latviešu valoda 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public LT = lietuvių kalba 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public HU = magyar 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public MT = Malti 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public NL = Nederlands 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public PL = polski 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public PT = português 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public RO = română 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public SK = slovenčina 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public SL = slovenščina 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public FI = suomi 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public SV = svenska 2008-01-13 2016-09-09
Nevanac : EPAR - Summary for the public HR = Hrvatski 2008-01-13 2016-09-09

This EPAR was last updated on 29/05/2017 .

Authorisation details

Product details

Product details for Nevanac
NameNevanac
Agency product numberEMEA/H/C/000818
Active substance

nepafenac

International non-proprietary name (INN) or common name

nepafenac

Therapeutic area Ophthalmologic Surgical ProceduresPain, Postoperative
Anatomical therapeutic chemical (ATC) code S01BC10

Publication details

Publication details for Nevanac
Marketing-authorisation holder

Novartis Europharm Limited

Revision13
Date of issue of marketing authorisation valid throughout the European Union11/12/2007

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

16/05/2017  Nevanac -EMEA/H/C/000818 -T/0035

Name Language First published Last updated
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29
Nevanac : EPAR - Product Information HR = Hrvatski 2009-02-12 2017-05-29

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23
Nevanac : EPAR - All Authorised presentations HR = Hrvatski 2008-01-13 2014-12-23

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Nevanac : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2008-01-13  
Nevanac : EPAR - Scientific Discussion HR = Hrvatski 2008-01-13