Xromi 100 mg/ml oral solution
*Company:
Nova Laboratories Ireland LimitedStatus:
UpdatedLegal 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
XromIE-PAT.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
The patient guide is updated in line with the extended indication > 9 months of age and the duration of contraception.
File name
XromIE-HCP.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
The HCP guide is updated to reflect the current indication > 9 months and duration of contraception.
Updated on 24 May 2024
File name
Summary of Product Characteristics.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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Updated on 24 May 2024
File name
Package Leaflet.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 March 2024
File name
Summary of Product Characteristics.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
The updates are in line with the extension of indication to patients over 9 months of age.
Updated on 28 March 2024
File name
Package Leaflet.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 3 - use in children/adolescents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The PIL is updated to extend the indication for patients over 9 months of age.
File name
XromIE-PAT.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of co-packaged devices.
File name
Xromi Physician Guide.pdf
Reasons for updating
- Add New Doc
File name
Xromi Patient Guide.pdf
Reasons for updating
- Replace File
File name
XromGB-PAT.pdf
Reasons for updating
- Replace File
Updated on 19 January 2023
File name
Package Leaflet.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
Xromi Summary of Product Characteristics.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.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
Package Leaflet.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
Xromi Patient Guide.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of the Risk Management Plan.
File name
Xromi Physician Guide.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update of the Risk Management Plan.
File name
Xromi Patient Guide.pdf
Reasons for updating
- Add New Doc
Updated on 30 November 2021
File name
Xromi Summary of Product Characteristics.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.pdf
Reasons for updating
- Replace File
Updated on 12 March 2021
File name
Package Leaflet.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 14 February 2021
File name
Summary of Product Characteristics.pdf
Reasons for updating
- Other
Legal category:Product subject to restricted prescription (C)
Updated on 07 February 2021
File name
Package Leaflet.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.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.pdf
Reasons for updating
- New PIL for medicines.ie
File name
Xromi Healthcare Professional Guide.pdf
Reasons for updating
- Add New Doc
Updated on 10 December 2019
File name
Summary of Product Characteristics.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.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 10 December 2019
File name
Package leaflet.pdf
Reasons for updating
- New PIL for new product