Distaclor LA Tablets 375mg

Product Information *

  • Company:

    Flynn Pharma Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 19 January 2021

File name

Distaclor PIL 375mg tab 2019_1611075648.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 January 2021

File name

Distaclor SmPC 375mg tab 2018_1611075553.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 date of revision 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 date of revision as per request from HPRA

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 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 16 August 2016

Reasons for updating

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

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

Free text change information supplied by the pharmaceutical company

Update Annex V information encouraging reporting of adverse events. Several additional minor changes to the product information to align with the QRD template.

Updated on 16 August 2016

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Update Annex V information encouraging reporting of adverse events. Several additional minor changes to the product information to align with the QRD template.

Updated on 13 July 2012

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 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

In section 1- added "prolonged release tablets"
In section 2- changed "for a full list of excipients, see section 6.1"
In section 6.1- Added "Tablet core" and " Tablet coating"
In section 9- Changed date of renewal " 16th June 2008"
In section 10- Changed date of revision "August 2009"

Updated on 13 July 2012

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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 1- added "prolonged release tablets"
In section 2- changed "for a full list of excipients, see section 6.1"
In section 6.1- Added "Tablet core" and " Tablet coating"
In section 9- Changed date of renewal " 16th June 2008"
In section 10- Changed date of revision "August 2009"

Updated on 14 March 2007

Reasons for updating

  • New SPC for medicines.ie

Updated on 14 March 2007

Reasons for updating

  • New SPC for medicines.ie

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