Distaclor LA Tablets 375mg
*Company:
Flynn Pharma LtdStatus:
No Recent UpdateLegal 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 23 May 2024
File name
ie-spc-375mg-tabs-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 23 May 2024
File name
2024-05-22_ie-pl-375mg-tabs-cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 23 May 2024
File name
2024-05-22_ie-spc-375mg-tabs-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 24 June 2022
File name
SmPC 375mg 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 375mg 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 375mg tab 2019.pdf
Reasons for updating
- New PIL for new product
Updated on 19 January 2021
File name
Distaclor SmPC 375mg 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
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
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
Updated on 28 February 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
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
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
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 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 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
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 March 2007
Reasons for updating
- New SPC for medicines.ie