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Minims Atropine Sulphate 1%w/v, Eye drops solution

*
Pharmacy Only: Prescription

  • Company:

    Bausch + Lomb Ireland Ltd.

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Atropine Sulfate

    *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

ie-pil-clean Word version.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

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

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_9648_990.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 01 August 2013

Reasons for updating

  • Correction of spelling/typing errors

Updated on 30 August 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 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 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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)

Free text change information supplied by the pharmaceutical company

1.       NAME OF THE MEDICINAL PRODUCT

 

          Minims Atropine Sulphate 1% w/v Eye Drops, solution.

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

          Atropine Sulphate 1% w/v.

 

          For a full list of excipients, see section 6.1.

 

6.1     List of Excipients

 

                   Hydrochloric acid (for pH adjustment)

                   Purified water

 


6.6     Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

                   For single use only. Discard any remaining solution.

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

 

          1 April 1979/ 1st April 2009

 

10.     DATE OF REVISION OF THE TEXT

          October 2009

Updated on 17 May 2005

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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

  • 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 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 22 August 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 August 2003

Reasons for updating

  • 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 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)