Distaclor LA Forte 500mg Tablet

*
Pharmacy Only: Prescription
  • 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 500mg tab 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

update to MAH address

Updated on 24 June 2022

File name

PIL mockup 500mg tab 2022 06 23.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Update to MAH address

Updated on 19 January 2021

File name

Distaclor PIL 500mg tab 2019.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 January 2021

File name

Distaclor 500mg tablets SmPC 500mg tab 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 to 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 to date of revision 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 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

  • 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