Milk of Magnesia

*
General Sale: Non-prescription
  • Company:

    Chefaro Ireland DAC
  • Status:

    No Recent Update
  • Legal Category:

    Supply through general sale
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 24 January 2023

File name

ie-spc-clean.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through general sale

Updated on 10 June 2020

File name

ie-spc-clean- consolidated-Nov2019.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Supply through general sale

Updated on 10 June 2020

File name

1.3.2-ie-mockup-leaflet-07-04-2020 2.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 21 April 2020

File name

131-uk-spc-rfi3-clean-17-03-2020.pdf

Reasons for updating

  • Improved presentation of SPC

Legal category:Supply through general sale

Updated on 21 April 2020

File name

131-uk-label-pil-rfi3-clean-17-03-2020.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 16 April 2020

File name

1.3.1-ie-label-leaflet-clean_07-04-2020.pdf

Reasons for updating

  • Addition of manufacturer
  • Change to date of revision

Updated on 27 January 2020

File name

ie-pl-clean-consolidated-Nov2019.pdf

Reasons for updating

  • Change to other sources of information section

Updated on 21 January 2020

File name

ie-pl-clean-consolidated-Nov2019.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Poduct information updated in line with the CCDS, with additional updates in line with the QRD template.

Updated on 21 January 2020

File name

ie-spc-clean- consolidated-Nov2019.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Poduct information updated in line with the CCDS, with additional updates in line with the QRD template.

Updated on 21 January 2020

File name

uk-pl-clean-0000.pdf

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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

 

The SmPC and PIL were updated in line with the newly created CCDS, in line with CMDh and MHRA guidance, all changes have been included in the CCDS due to their medical relevance, and rely on the same supporting data package.

Updated on 26 July 2019

File name

ie-mockup-label.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 07 June 2019

File name

ie-label-leaflet-approved 19-11-2018.pdf

Reasons for updating

  • Change to MA holder contact details

Updated on 07 June 2019

File name

ie-spc-clean app 31-05-2019.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through general sale

Updated on 23 November 2018

File name

ie-spc-approved-19-11-2018.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 21 November 2018

File name

ie-label-leaflet-approved 19-11-2018.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 20 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 20 November 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7 - address of the MAH has been updated.

Updated on 17 November 2017

File name

PIL_16384_809.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 November 2017

Reasons for updating

  • Change to MA holder contact details

Updated on 26 June 2015

Reasons for updating

  • New PIL for new product

Updated on 15 September 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

update the revision date to reflect the variation approval date

Updated on 14 February 2014

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 6.5 (nature and contents of container) the cap material has been corrected to HDPE.

Updated on 23 August 2013

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided