Laxido Orange, powder for oral solution
*Company:
Galen Pharma Ireland LimitedStatus:
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 January 2023
File name
01-1.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 December 2021
File name
01-1.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 07 December 2021
File name
01-1.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 April 2019
File name
01-1.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 April 2019
File name
01-1.pdf
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 February 2019
File name
02-1.pdf
Reasons for updating
- Addition of manufacturer
- Change to date of revision
Updated on 07 December 2018
File name
02-1.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
Updated on 07 December 2018
File name
02-1.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 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
Information regarding the sodium content of the product was added to Section 2 of the SPC, in line with the newly updated Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’.Updates in line with the current EU product information requirements (QRD template).
Updated on 17 August 2018
File name
02-1.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 August 2018
File name
0026.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 March 2016
File name
PIL_14354_865.pdf
Reasons for updating
- New PIL for new product
Updated on 02 March 2016
Reasons for updating
- Change to date of revision
Updated on 04 January 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 January 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- 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 24 December 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 10 June 2015
Reasons for updating
- SPC retired pending re-submission
- 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
The renewal for Laxido Orange has been approved. The date of revision of the SPC has been updated, as a result of this renewal.
Updated on 07 May 2014
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The following sections of the SPC have been updated:
4.6 Fertility, pregnancy and lactation
4.8 Undesirable effects
5.3 Preclinical safety data
Updated on 06 May 2014
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 09 July 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 04 July 2012
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 08 September 2009
Reasons for updating
- Change to date of revision
- PIL retired pending re-submission
Updated on 04 August 2009
Reasons for updating
- New PIL for medicines.ie
Updated on 12 February 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.5 an additional pack size (100 sachet) has been added
Updated on 12 February 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- SPC retired pending re-submission
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 10: Date of revision updated
Updated on 28 October 2008
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)