Distaclor 250mg Granules for Oral Suspension

  • Company:

    Flynn Pharma Ltd
  • Status:

    No Recent Update
  • Legal 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 24 June 2022

File name

SmPC 250mg OS 2022 06 23.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

MAH address change

Updated on 24 June 2022

File name

PIL mockup OS 2022 06 23.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

MAH address change

Updated on 03 March 2021

File name

Distaclor 250mg suspensionSmPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free

Updated on 03 March 2021

File name

Distaclor Suspension PIL 2021 03 02.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free.

Updated on 03 March 2021

File name

PIL_17393_720.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free

Updated on 19 January 2021

File name

Distaclor SmPC 250mg suspension 2018.pdf

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 12 March 2018

Reasons for updating

  • New SPC for new product

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

Updated on 12 March 2018

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)

Free text change information supplied by the pharmaceutical company

Update revision date as per request from HPRA

Updated on 12 March 2018

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update revision date as per request from HPRA

Updated on 28 February 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Update MA holder address

Updated on 28 February 2018

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Update MA holder address

Updated on 05 February 2018

File name

PIL_17393_720.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 July 2012

Reasons for updating

  • New SPC for medicines.ie

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 13 July 2012

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided