Minims Artificial Tears, Eye drops solution
*Company:
Bausch + Lomb Ireland Ltd.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 July 2022
File name
ie-spc-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2022
File name
ie-pil-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 21 May 2020
File name
spc clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 May 2020
File name
leaflet clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 December 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 December 2015
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 July 2015
File name
PIL_9151_761.pdf
Reasons for updating
- New PIL for new product
Updated on 28 July 2015
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 30 August 2012
Reasons for updating
- Correction of spelling/typing errors
Updated on 30 July 2012
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
All SPCs on Medicines.ie have been updated for Bausch + Lomb following personnel changes to ensure accuracy of information.
Updated on 13 August 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hyetellose Ph. Eur. 0.44% w/w and Sodium chloride Ph. Eur. 0.35% w/w.
For full list of excipients, see section 6.1.
6.5 Nature and Contents Of Container
A sealed conical shaped container fitted with a twist and pull off cap made from Ph. Eur. grade polypropylene for containers and closures for parenteral and ophthalmic preparations. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution. There are 20 Minims units in every carton.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of first authorisation: 23 March 1992
Date of the last renewal: 23 March 2007
Updated on 23 July 2008
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change from the BAN of the active substance to the rINN
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 May 2005
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 16 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 21 July 2003
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 July 2003
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)