Brolene 0.1%w/v Eye Drops Solution

Product Information *

  • Company:

    SANOFI
  • Status:

    Updated
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through pharmacy only

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12 July 2021

File name

Brolene Eye Drops Solution PIL_1626105356.pdf

Reasons for updating

  • XPIL Removed

Updated on 06 July 2020

File name

Brolene Eye Drops Solution PIL.pdf

Reasons for updating

  • XPIL Removed

Updated on 08 August 2019

File name

Brolene Eye Drops Solution PIL.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 October 2018

File name

Brolene Eye Drops Solution PIL.pdf

Reasons for updating

  • XPIL Created

Updated on 18 May 2018

File name

Brolene Eye Drops Solution PIL.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 07 May 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.8 updated to include the new PV Legislation wording on adverse effect reporting.

Updated on 07 May 2014

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 02 May 2014

File name

PIL_8355_749.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 May 2014

Reasons for updating

  • Addition of manufacturer

Updated on 24 September 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7 updated to include 'T/A SANOFI'

Updated on 15 March 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update Section 4.8 - eye pain irritation

Updated on 10 March 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 07 January 2009

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update Section 6.3 of SPC Shelf Life

Updated on 14 October 2008

Reasons for updating

  • Improved electronic presentation

Updated on 14 October 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 17 September 2007

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update section 2
Propamidine Isethionate changed to Propamidine Isetionate

Updated on 17 September 2007

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2006

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update Section
7 - Change MAH to sanofi aventis Ireland Ltd.
10 - Date of revision

Updated on 19 August 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 February 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 28 January 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 07 November 2003

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 03 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only