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:
    info
  • Active Ingredients:

    Vedolizumab

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/03/21

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Summary of Product Characteristics last updated on medicines.ie: 30/3/2021

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Entyvio 108 mg solution for injection in pre-filled syringe/pre-filled pen Active Ingredients Vedolizumab
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1 - 0 of 62 items.Total: Infinity pages

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 30 March 2021 SPC

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 PIL

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 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