Daxas 250 mcg Film-Coated Tablets *

  • Company:

    AstraZeneca Pharmaceuticals (Ireland) DAC
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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 24 September 2021

File name

20210920 SPC IE MT NI Daxas 250mcg Postpone PASS Final Study Report RSP 21 0009_1632500109.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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

Updated on 24 September 2021

File name

20210920 Package Leaflet IE MT NI Daxas 250mcg Postpone PASS Final Study Report RSP 21 0011_1632499807.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 September 2020

File name

20200904 SPC IE MT Daxas Tablets 250mcg Addition of Corden as BR site RSP 20 0022_1599839501.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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

Updated on 11 September 2020

File name

20200904 Package Leaflet IE MT Daxas Tablets 250mcg Addition of Corden as BR site RSP 20 0020_1599839450.pdf

Reasons for updating

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

Updated on 04 June 2020

File name

20200520 SPC IE MT Daxas Tablets 250mcg Renewal RSP 20 0012_1591260915.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 04 June 2020

File name

20200520 Package Leaflet IE MT Daxas Tablets 250mg Renewal RSP 20 0011_1591260734.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 24 April 2020

File name

20200424 SPC IE MT Daxas Tablets 250 mg Type IA VAR RSP 20 0006_1587749291.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 10 - Date of revision of the text

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

Updated on 23 January 2020

File name

20200116-Package Leaflet-IE-MT-Daxas-Tablets-250mg-Type II var RSP 19 0011_1579776759.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 23 January 2020

File name

20200116-SPC-IE-MT-Daxas-Tablets-250mg-Type II var RSP 19 0009_1579776649.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

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

Updated on 17 October 2018

File name

2018-04-23 PIL Daxas 250mcg tab UIM RSP 18 0017_1539783996.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 October 2018

File name

2018-04-23 SmPC Daxas 250mcg tab UIM RSP 18 0016_1539784081.pdf

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

New product.