Palexia Oral Solution 4mg/ml
*Company:
Grunenthal Pharma Ltd.Status:
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
![PALEXIA-OS-4MG-[Left].jpeg](https://backend-prod.medicines.ie/uploads/files/PALEXIA-OS-4MG-[Left]_1624023600.jpeg)
Updated on 04 September 2024
File name
ie-leaflet-2242-12-10-v15-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - excipient warnings
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type II approval to remove the restrictions to a maximum treatment duration of 72-hour for the paediatric population, to update the PIL per EU excipient guidelines EMA/CHMP/302620/2017 Rev. 2 for Palexia 4mg/ml oral solution.
Updated on 04 September 2024
File name
m1-3-1-spc-2242-12-10-v16-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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
Type II approval to remove the restrictions to a maximum treatment duration of 72-hour for the paediatric population, to update the PIL per EU excipient guidelines EMA/CHMP/302620/2017 Rev. 2 for Palexia 4mg/ml oral solution.
Updated on 27 February 2023
File name
ie-leaflet-2242-12-10-v14-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
- Change to further information section
Updated on 27 February 2023
File name
m1-3-1-spc-2242-12-10-v15-clean.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 January 2023
File name
m1-3-1-spc-2242-12-10-v14-clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 June 2021
File name
m1-3-1-leaflet-2242-12-10-v11-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
Updated on 08 June 2021
File name
m1-3-1-spc-2242-12-10-v14-clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 March 2020
File name
m1-3-1-spc-2242-12-10-v13-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
addition of information on sleep-related breathing disorders
Updated on 05 March 2020
File name
m1-3-1-leaflet-2242-12-10-v10-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
addition of information on sleep-related breathing disorders
Updated on 25 November 2019
File name
m1-3-1-spc-2242-12-10-v12-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 November 2019
File name
m1-3-1-leaflet-2242-12-10-v9-clean.pdf
Reasons for updating
- New PIL for new product