Lixiana Film-Coated Tablets
- Name:
Lixiana Film-Coated Tablets
- Company:
Daiichi Sankyo Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/12/20
(Click to Download)Click on this link to Download PDF directly
Daiichi Sankyo Ireland Ltd
Company Products
| Medicine Name | Active Ingredients |
|---|---|
| Medicine Name BENETOR 10mg, 20 mg and 40 mg film-coated tablets | Active Ingredients olmesartan medoxomil |
| Medicine Name BENETOR PLUS 20mg/12.5mg and 20mg/25mg film-coated tablets | Active Ingredients Hydrochlorothiazide, olmesartan medoxomil |
| Medicine Name Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Ltd) | Active Ingredients prasugrel hydrochloride |
| Medicine Name Evista | Active Ingredients Raloxifene |
| Medicine Name Lixiana Film-Coated Tablets | Active Ingredients Edoxaban tosilate |
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.
Updated on 7 December 2020 SPC
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 7 December 2020 PIL
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
Updated on 17 November 2020 Ed-Ptnt
Reasons for updating
- Replace document
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 17 November 2020 SPC
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 PIL
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 SPC
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 8 April 2020 PIL
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
Updated on 8 April 2020 Ed-Ptnt
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 8 April 2020 SPC
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 2 July 2019 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Lixiana Patient Alert CardRisk Minimisation Materials
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