Keflex 125mg/5ml Powder for Oral Suspension

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 17 March 2021

File name

Keflex OS SmPC 125mg 2021 03 10_1615975279.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_1615975007.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_1615975007.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_1566979385.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

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

Free text change information supplied by the pharmaceutical company

General updates in line with QRD requirements

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

General updates in line with QRD requirements

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 13 July 2012

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

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