Brolene 0.1%w/v Eye Drops Solution
- Name:
Brolene 0.1%w/v Eye Drops Solution
- Company:
SANOFI
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20


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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
SANOFI

Company Products
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 SPC
Reasons for updating
- New SPC 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
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
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
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
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
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
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