Xromi 100 mg/ml oral solution

*
Pharmacy Only: Prescription

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.

EDM Updated on 20 September 2023

File name

XromIE-PAT.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Update of co-packaged devices.

EDM Updated on 20 September 2023

File name

Xromi Physician Guide.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 17 May 2023

File name

Xromi Patient Guide.pdf

Reasons for updating

  • Replace File

EDM Updated on 17 May 2023

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.

EDM Updated on 17 May 2022

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.

EDM Updated on 17 May 2022

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.

EDM Updated on 17 May 2022

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)

EDM Updated on 28 June 2021

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

EDM Updated on 10 December 2019

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