Cleenema Ready-to-Use 21.4g / 9.4g Enema

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Pharmacy Only: Non-prescription

Updated on 15 April 2024

File name

IE_Cleenema_PIL_062022.pdf

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 23 August 2022

File name

IE_Cleenema_SmPC_062022.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Supply through pharmacy only

Updated on 23 June 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 23 June 2017

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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

Product name has been changed from Fleet Ready-to-Use 21.4g / 9.4g Enema to Cleenema Ready-to-Use 21.4g / 9.4g Enema

Updated on 22 June 2017

File name

PIL_16338_297.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 June 2017

Reasons for updating

  • Change to name of medicinal product

Updated on 12 November 2015

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

Free text change information supplied by the pharmaceutical company

Section 7 MA holder has been changed to Casen Recordati S.L.  MA holders address remains the same.
Section 8 MA number has been changed to PA2028/001/001
Section 10 Revision of the text is dated August 2015.

Updated on 12 November 2015

Reasons for updating

  • Change of manufacturer
  • Change of licence holder
  • Change to date of revision

Updated on 28 May 2015

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 May 2015

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided