Edarbi Tablets

Product Information *

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 03 February 2021

File name

Edarbi SmPC IRE 19 Jan 2021_1612341461.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of section 4.4. with sodium content wording
Change in section 7 address of the marketing authorisation holder

Updated on 03 February 2021

File name

Edarbi PIL IRE 19 Jan 2021_1612341406.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 18 February 2020

File name

m1-3-1-Leaflet-Edarbi-IRE-06.01.2020_1582034340.pdf

Reasons for updating

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

Updated on 22 March 2019

File name

m1-3-1-SPC-Edarbi-IRE-20.03.2018_1553269433.pdf

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

File name

m1-3-1-Leaflet-Edarbi-IRE-20.03.2018_1550854239.pdf

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

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

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

File name

PIL_15407_479.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 November 2016

Reasons for updating

  • Removal of black triangle

Updated on 20 November 2014

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 02 October 2014

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

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

Reasons for updating

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

Updated on 10 March 2014

Reasons for updating

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

Updated on 06 January 2014

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 03 July 2012

Reasons for updating

  • New PIL for new product