Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 08 December 2022
File name
ie-spc-augmentinduomf400-57mgissue6draft3 (2).pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 December 2022
File name
ie-pl-augmentinduomf400-57mgissue8draft2 (3).pdf
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
Updated on 05 March 2021
File name
ie-pl-augmentinduomf400-57mgissue7draft1.pdf
Reasons for updating
- Change of manufacturer
Free text change information supplied by the pharmaceutical company
Removal of Inactive Batch Release Site
Updated on 10 August 2020
File name
ie-spc-augmentinduomf400-57mgissue5 draft2.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 August 2020
File name
ie-pl-augmentinduomf400-57mgissue5draft1-medicines.ie.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 20 December 2019
File name
ie-spc-augmentinduomf400-57mgissue4draft1-medicines.ie.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to SmPC
Section 6.5 –Type of cap and bottle seal
Section 6.6 – Preparation and reconstitution methods
Updated on 20 December 2019
File name
ie-pl-augmentinduomf400-57mgissue5draft1-medicines.ie.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to other sources of information section
Updated on 16 April 2019
File name
ie-pl-augmentinduomf400-57mgissue4draft1 for medicines.ie.pdf
Reasons for updating
- New PIL for new product
Updated on 16 April 2019
File name
ie-spc-augmentinduomf400-57mgissue3draft1 for medicines.ie.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)