Entyvio 108 mg solution for injection in pre-filled syringe/pre-filled pen
- Name:
Entyvio 108 mg solution for injection in pre-filled syringe/pre-filled pen
- Company:
Takeda Products Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/11/20

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Takeda Products Ireland Ltd

Company Products
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 17 November 2020 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 7:
New MAH address added:
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
In section 10: date of revision updated to 21st October 2020
Updated on 17 November 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
New MAH address added:
Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Denmark
Date of revision updated to October 2020
Updated on 29 October 2020 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 5.1 Pharmacodynamic properties:
The primary and secondary endpoints were analysed in subgroups of patients who had failed prior TNFα antagonist therapy (37%; n = 804) and patients who were naïve to previous TNFα antagonist therapy (63%; n = 136). Results of study patients treated with placebo and subcutaneous vedolizumab in these subgroups are presented in Table 5.
In section 6.3 Shelf life:
2418 months
In section 10. DATE OF REVISION OF THE TEXT:
28 April 2020 25 September 2020
Updated on 12 June 2020 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 12 June 2020 Ed-HCP
Reasons for updating
- Add New Doc
Updated on 11 May 2020 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 11 May 2020 PIL
Reasons for updating
- New PIL for new product
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