Minims Artificial Tears, Eye drops solution *

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 21 May 2020

File name

spc clean_1590055482.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_1590055414.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

QRD update and update to section 4.8 of SPC

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

change in marketing authorisation  holder and date of revision of text

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

Sections 1, 2 and 3 : change in the wording following renewal of the product
 
Sections 2 and 5.1: change in the name of API from Hydroxyethylcellulose to Hyetellose (INN)

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)