Lixiana Film-Coated Tablets *

  • Company:

    Daiichi Sankyo Ireland Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

EDM Updated on 01 October 2021

File name

Lixiana prescriber guide (MDK8814)-V07a-printable version-(tab crushing-PRAC-DUS)-280921_1633081861.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Printable version 

EDM Updated on 17 June 2021

File name

Lixiana prescribing guide -V07-(tab crushing-PRAC DUS)-clean-120521_1623940285.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Updated following variation addition of tablet crishing and also update following PRAC-DUS

EDM Updated on 30 April 2021

File name

Lixiana Prescriber Guide-V06-(removal blk triangle-renal func NVAF)-010421_1619776446.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Removal of black triangle 

updated statement for Special Patient Populations: Renal function in NVAF to exactly reflect the wording as per the relevant SPC section

Updated on 07 December 2020

File name

SmPC-Lixiana-combined-V09-(Tab crushing & bottle)-261120-clean_1607333383.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated for advise tablet crushing

Addition of pack size: bottle x 90

Updated on 07 December 2020

File name

Lixiana-PIL-combined-V07-(Tab crushing & bottle)-261120-clean_1607333306.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Addition of advise on tablet curshing and addition of pack size: bottle x 90

EDM Updated on 17 November 2020

File name

PAC-Lixiana~V04-(Removal Blk Triangle)-291020.clean_1605619873.pdf

Reasons for updating

  • Replace File

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle

Updated on 17 November 2020

File name

SmPC-Lixiana-combined-V08-(removal blk triangle)-291020-clean_1605619817.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle dated: 29/10/2020

Updated on 17 November 2020

File name

Lixiana-PIL-combined~V06-(Removal Blk Triangle)-291020-clean_1605619734.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle approved:29/10/2020

Updated on 10 July 2020

File name

SmPC-Lixiana-combined~V07-(PAM E314-)-250620-clean_1594372264.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update following approval variation PAM E314

Updated on 08 April 2020

File name

Lixiana-PIL-combined~V05-(Renewal)-240220-clean_1586366980.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Updated during Renewal porcedure.

Update to sections:

  • 1. What Lixiana is and what it is used for
  • 2. Do not take Lixiana
  • 2. Warning s and precautions
  • 2. Other medicines and Lixiana 
  • 4. Possible Side Effects
  • 6. Contents of the pack and other information
  • other sources of information

EDM Updated on 08 April 2020

File name

Patient-Alert-Card~V03-(Renewal)-240220-clean_1586366652.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Updated following approval of renewal procedure.

Update to sections:

  • Treatment information
  • Information for Healthcare Professionals
  • About your treatment

Updated on 08 April 2020

File name

SmPC-Lixiana-combined~V06-(Renewal)-240220-clean_1586366491.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC updated following Renewal procedure including several text revisions, including the QRD 10.1 update and further stylistic and content changes

Updated on 02 July 2019

File name

SmPC-Lixiana-combined~V05-(IA APS update & combine)-250619-clean_1562074240.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)