Xromi 100 mg/ml oral solution *
Pharmacy Only: Prescription

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.

EDM Updated on 17 May 2022

File name

62836b2ec9d9a.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

62836ab8348ce.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

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)

EDM Updated on 28 June 2021

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

EDM Updated on 10 December 2019

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