Keflex 125mg/5ml Powder for Oral Suspension
*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 24 June 2022
File name
SmPC 125mg 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 suspensions 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 03 September 2021
File name
SmPC 125mg OS 2021 09 02.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Remove details regarding dilution with Syrup BP
Updated on 17 March 2021
File name
Keflex OS SmPC 125mg 2021 03 10.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
Section 4.4: to add warning regarding sodium content. As per the excipient guidelines, this is to confirm that as there is less than 1mmol of sodium per dose, the medicine is considered essentially sodium free
Updated on 17 March 2021
File name
Keflex PIL 2021 02 03.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
Section 2 : to add warning regarding sodium content. As per the excipient guidelines, this is to confirm that as there is less than 1mmol of sodium per dose, the medicine is considered essentially sodium free
Updated on 17 March 2021
File name
Keflex PIL 2021 02 03.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Section 2 : to add warning regarding sodium content. As per the excipient guidelines, this is to confirm that as there is less than 1mmol of sodium per dose, the medicine is considered essentially sodium free
Updated on 28 August 2019
File name
Irish-SmPC-125mg-suspension-approved-230418.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 08 June 2018
File name
Irish-SmPC-125mg-suspension-approved-230418.docx
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 the MA holder address details
Updated on 20 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 June 2017
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 20 June 2017
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
- 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
Updated on 13 July 2012
Reasons for updating
- New SPC for medicines.ie