Yellox

bromfenac

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This is a summary of the European public assessment report (EPAR) for Yellox. 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 Yellox.

What is Yellox?

Yellox is an eye drop solution that contains the active substance bromfenac.

What is Yellox used for?

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

The medicine can only be obtained with a prescription.

How is Yellox used?

The dose of Yellox is one drop into the affected eye(s) twice a day beginning the day after the cataract operation and continued for two weeks. Treatment should not exceed two weeks.

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

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.

How has Yellox been studied?

The effects of Yellox were first tested in experimental models before being studied in humans.

In two main studies, Yellox was compared with placebo (a dummy treatment) in 527 patients with inflammation following cataract surgery. The main measure of effectiveness was the number of patients with no signs of inflammation after two weeks.

What benefit has Yellox shown during the studies?

Yellox was more effective than placebo in treating inflammation in the eye following cataract surgery. 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 is the risk 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 should not be used in people who may be 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 has Yellox been approved?

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

Other information about Yellox

The European Commission granted a marketing authorisation valid throughout the European Union for Yellox to Croma-Pharma GmbH on 18 May 2011. The marketing authorisation is valid for five years, after which it can be renewed.

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

This EPAR was last updated on 03/10/2013 .

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
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Yellox
Marketing-authorisation holder

Croma-Pharma GmbH

Revision3
Date of issue of marketing authorisation valid throughout the European Union18/05/2011

Contact address:

Croma-Pharma GmbH
Industriezeile 6
AT-2100 Leobendorf
Austria

Product information

Product information

14/08/2013  Yellox -EMEA/H/C/001198 -IAIN/0006

Name Language First published Last updated
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013
Yellox : EPAR - Product Information SV = svenska 14/06/2011 03/10/2013

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 SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  
Yellox : EPAR - All Authorised presentations SV = svenska 14/06/2011  

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Treatment of postoperative ocular inflammation following cataract extraction in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Yellox : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 04/08/2011 03/10/2013

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union