Laxido Orange, powder for oral solution
- Name:
Laxido Orange, powder for oral solution
- Company:
Galen Pharma Ireland Limited
- Active Ingredients:
Macrogol 3350, Potassium Chloride, Sodium Chloride, Sodium Hydrogen Carbonate
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/04/19
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Galen Pharma Ireland Limited
Company Products
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 25 April 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 25 April 2019 SmPC
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 PIL
Reasons for updating
- Addition of manufacturer
- Change to date of revision
Updated on 7 December 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
Updated on 7 December 2018 SmPC
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 SmPC
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 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 2 March 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 2 March 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 4 January 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 4 January 2016 SmPC
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 PIL
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 SmPC
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 7 May 2014 SmPC
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 6 May 2014 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 9 July 2012 SmPC
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 4 July 2012 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 8 September 2009 PIL
Reasons for updating
- Change to date of revision
- PIL retired pending re-submission
Updated on 4 August 2009 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 12 February 2009 SmPC
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 12 February 2009 SmPC
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 28 October 2008 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)