Entyvio 108 mg solution for injection in pre-filled pen
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 March 2024
File name
ie-Entyvio-pil-sc-pen-clean Mar 2024.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 15 March 2024
File name
ie-Entyvio-spc-sc-pen-clean Mar 2024.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 July 2023
File name
ie-pil-sc pen-clean-PASS study-Jul2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Possible side effects updated.
Date of revision updated.
Updated on 14 July 2023
File name
ie-spc-sc pen-clean-PASS study-Jul2023.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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
4.8 update to undesirable effects
Date of Revision updated.
Updated on 09 May 2023
File name
ie-spc-sc pen-non multipack-clean-Apr2023.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 May 2023
File name
ie-pil-sc pen-non multipack-clean-Apr2023.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to storage instructions
- Change to further information section
Updated on 01 February 2023
File name
m1-3-1-spc-sc-syringe deletion-IRE(Valid from 01-Feb-2023)-clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Deletion of the Entyvio 108 mg solution for injection in pre-filled syringe format and all information related to this format.
Updated on 01 February 2023
File name
m1-3-1-leaflet-text-SC-syringe deletion-IRE(Valid from 01-Feb-2023)-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
Free text change information supplied by the pharmaceutical company
Deletion of all details in relation to the Entyvio (vedolizumab) 108 mg solution for injection in pre-filled syringe.
Updated on 22 March 2022
File name
Entyvio SC PIL IE.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 15 November 2021
File name
ie-pil-sc-clean_October 2021.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 15 November 2021
File name
ie-spc-sc-clean_14 October 2021.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2021
File name
Entyvio SmPC SC IE 22.03.2021.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of Interstitial lung disease (frequency unknown) to SPC Section 4.8 Undesirable effects
Clarification of frequency not known category in the text preceding ADR table in SPC
Updated on 30 March 2021
File name
Entyvio PIL SC IE 22.03.2021.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of Interstitial lung disease (frequency unknown) to Section 4. Possible side effects
Updated on 17 November 2020
File name
Entyvio SmPC SC IRE 21.10.2020.pdf
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
File name
Entyvio PIL SC IRE 21.10.2020.pdf
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
File name
m1-3-1-SmPC-entyvioSC-IRE-clean.pdf
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 11 May 2020
File name
Entyvio SmPC SC IRE 28.04.2020.pdf
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
File name
Entyvio PIL SC IRE 28.04.2020.pdf
Reasons for updating
- New PIL for new product