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Brolene 0.1%w/v Eye Drops Solution

  • Name:

    Brolene 0.1%w/v Eye Drops Solution

  • Company:
    info
  • Active Ingredients:

    Propamidine Isethionate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 7/5/2014
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1 - 0 of 174 items.Total: Infinity pages

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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 8 August 2019 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 October 2018 PIL

Reasons for updating

  • XPIL Created

Updated on 18 May 2018 PIL

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 7 May 2014

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 7 May 2014 SPC

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 2 May 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 May 2014 PIL

Reasons for updating

  • Addition of manufacturer

Updated on 24 September 2012 SPC

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 SPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 7 January 2009 SPC

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 SPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 14 October 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 September 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 September 2007 SPC

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 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2006 SPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 February 2004 SPC

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 SPC

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 7 November 2003 SPC

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 3 June 2003 SPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only