Daxas 250 micrograms tablets

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Pharmacy Only: Prescription

Updated on 21 March 2024

File name

20240219 Package Leaflet IE MT Daxas 250mcg Takeda BR removal RSP 24 0006.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 November 2023

File name

20231115 SPC IE MT Daxas 250mcg PASS Final Study Report RSP 23 0022.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

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

Updated on 23 November 2023

File name

20231115 Package Leaflet IE MT Daxas 250mcg PASS Final Study Report RSP 23 0020.pdf

Reasons for updating

  • Removal of Black Inverted Triangle

Updated on 19 January 2023

File name

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

Reasons for updating

  • Document format updated

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

Updated on 24 September 2021

File name

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