Yellox

bromfenac

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This is a summary of the European public assessment report (EPAR) for Yellox. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Yellox.

For practical information about using Yellox, patients should read the package leaflet or contact their doctor or pharmacist.

What is Yellox and what is it used for?

Yellox is a medicine used in adults to treat inflammation in the eye that can occur after an operation to remove a cataract (clouding of the lens).

Yellox contains the active substance bromfenac.

How is Yellox used?

Yellox is available as an eye drop solution and the recommended dose is one drop into the affected eye(s) twice a day. Treatment begins the day after the cataract operation and continues for two weeks.

If more than one eye medicine is being used, they should be given at least five minutes apart.

The medicine can only be obtained with a prescription. For more information see the package leaflet.

How does Yellox work?

The active substance in Yellox, bromfenac, 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, Yellox can reduce the inflammation caused by eye surgery.

What benefits of Yellox have been shown during the studies?

Yellox was found to be more effective than placebo (a dummy treatment) at relieving inflammation in the eye following cataract surgery in two main studies involving a total of 527 patients undergoing cataract surgery. In both studies, the main measure of effectiveness was the number of patients with no sign of inflammation after two weeks. In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73). In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.

What are the risks associated with Yellox?

The most common or most important side effects seen with Yellox are abnormal sensation in eye (0.5%), mild or moderate erosion of the cornea (the transparent layer in front of the eye) (0.4%), eye pruritus (itching) (0.4%), eye pain (0.3%) and eye redness (0.3%). For the full list of all side effects reported with Yellox, see the package leaflet.

Yellox must not be used in people who are hypersensitive (allergic) to bromfenac, to any of the other ingredients or to other NSAIDs. It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.

Why is Yellox approved?

The European Medicines Agency decided that Yellox’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 Yellox?

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

Other information about Yellox

The European Commission granted a marketing authorisation valid throughout the European Union for Yellox on 18 May 2011.

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

Name Language First published Last updated
Yellox : EPAR - Summary for the public BG = bălgarski 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public ES = español 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public CS = čeština 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public DA = dansk 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public DE = Deutsch 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public ET = eesti keel 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public EL = elliniká 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public EN = English 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public FR = français 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public IT = italiano 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public LV = latviešu valoda 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public LT = lietuvių kalba 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public HU = magyar 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public MT = Malti 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public NL = Nederlands 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public PL = polski 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public PT = português 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public RO = română 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public SK = slovenčina 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public SL = slovenščina 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public FI = suomi 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public SV = svenska 2011-06-14 2017-11-17
Yellox : EPAR - Summary for the public HR = Hrvatski 2011-06-14 2017-11-17

This EPAR was last updated on 17/11/2017 .

Authorisation details

Product details

Product details for Yellox
NameYellox
Agency product numberEMEA/H/C/001198
Active substance

bromfenac sodium sesquihydrate

International non-proprietary name (INN) or common name

bromfenac

Therapeutic area Ophthalmologic Surgical ProceduresPain, Postoperative
Anatomical therapeutic chemical (ATC) code S01BC11

Publication details

Publication details for Yellox
Marketing-authorisation holder

PharmaSwiss Ceska Republika s.r.o

Revision8
Date of issue of marketing authorisation valid throughout the European Union18/05/2011

Contact address:

PharmaSwiss Ceska Republika s.r.o
Jankovcova 1569/2c
Lighthouse
17000 Prague 7
Czech Republic

Product information

Product information

05/04/2017  Yellox -EMEA/H/C/001198 -N/0019

Name Language First published Last updated
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04
Yellox : EPAR - Product Information HR = Hrvatski 2011-06-14 2017-05-04

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
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  
Yellox : EPAR - All Authorised presentations HR = Hrvatski 2011-06-14  

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Treatment of postoperative ocular inflammation following cataract extraction in adults.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Yellox : EPAR - Public assessment report HR = Hrvatski 2011-06-14  
CHMP summary of positive opinion for Yellox HR = Hrvatski 2011-03-18  

Authorised

This medicine is approved for use in the European Union