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Edarbi Tablets

  • Name:

    Edarbi Tablets

  • Company:
    info
  • Active Ingredients:

    Azilsartan medoxomil potassium

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/02/20

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Summary of Product Characteristics last updated on medicines.ie: 22/3/2019

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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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 18 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 March 2019 SPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

A variation to introduce an alternative type of blister (non-desiccated) in addition to the currently approved blister (with desiccant) was approved for Edarbi on 20th March 2018. 

Updated on 22 February 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 21 December 2016 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 21 December 2016 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • Removal of black triangle

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

Free text change information supplied by the pharmaceutical company

Change to section

Details of change

 

Removal of Black triangle.

4.2 Posology and method of administration

Removal of the following wording:

Heart failure

Caution should be exercised in hypertensive patients with congestive heart failure as there is no experience of use of Edarbi in these patients (see section 4.4

 

10. Date of revision of the text

9 September 2014

14 November 2016

Updated on 28 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 November 2016 PIL

Reasons for updating

  • Removal of black triangle

Updated on 20 November 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 2 October 2014 SPC

Reasons for updating

  • Addition of joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 26 September 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 13 June 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 10 March 2014 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 6 January 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 3 July 2012 PIL

Reasons for updating

  • New PIL for new product