Xromi 100 mg/ml oral solution * Pharmacy Only: Prescription
Company:
Nova Laboratories Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
650b1769bcf0c.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of co-packaged devices.
File name
650b169f60459.pdf
Reasons for updating
- Add New Doc
File name
6464b1c9a2d92.pdf
Reasons for updating
- Replace File
File name
6464b0289bffe.pdf
Reasons for updating
- Replace File
Updated on 19 January 2023
File name
63c92fb95787c.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Update of co-packaged medical devices (3 ml and 10 ml).
Updated on 19 January 2023
File name
63c92c195ed0f.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of co-packaged medical devices (3 ml and 10 ml).
Updated on 19 January 2023
File name
Xromi Summary of Product Characteristics_1638277656.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of medical devices, 3 ml and 10 ml.
Updated on 09 June 2022
File name
62a1da33c3aac.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
The text of the Package Leaflet was also updated with the approval date of the change.
File name
62836b2ec9d9a.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of the Risk Management Plan.
File name
62836ab8348ce.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of the Risk Management Plan.
File name
62836a8fe84db.pdf
Reasons for updating
- Add New Doc
Updated on 30 November 2021
File name
Xromi Summary of Product Characteristics_1638277656.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to restricted prescription (C)
File name
Xromi Physician Guide_06-2021_1624863681.pdf
Reasons for updating
- Replace File
Updated on 12 March 2021
File name
Package Leaflet_1615568429.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 February 2021
File name
Summary of Product Characteristics_1613310340.pdf
Reasons for updating
- Other
Legal category:Product subject to restricted prescription (C)
Updated on 07 February 2021
File name
Package Leaflet_1612703569.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - manufacturer
- Change to side-effects
- Addition of manufacturer
Updated on 07 February 2021
File name
Summary of Product Characteristics_1612702010.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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to restricted prescription (C)
Updated on 10 December 2019
File name
Package leaflet_1575977029.pdf
Reasons for updating
- New PIL for medicines.ie
File name
Xromi Healthcare Professional Guide_1575977692.pdf
Reasons for updating
- Add New Doc
Updated on 10 December 2019
File name
Summary of Product Characteristics_1575977386.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 10 December 2019
File name
Package leaflet_1575977029.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 10 December 2019
File name
Package leaflet_1575977029.pdf
Reasons for updating
- New PIL for new product