Sirdupla 25 microgram/125 microgram, 25 microgram/250 microgram per metered dose pressurised inhalation, suspension *
Pharmacy Only: Prescription

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 02 December 2020

File name

ie-pl-clean-de5724-v020_1606923372.pdf

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Change to name of product in Italy

Updated on 07 October 2020

File name

ie-spc-clean-de5724-r001_1602086392.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 05 June 2020

File name

ie-spc-clean-de5724-v019_1591373560.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 05 June 2020

File name

ie-pl-clean-de5724-v019_1591373112.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 04 November 2019

File name

ie-spc-clean-de5724-v017_1572871891.pdf

Reasons for updating

  • 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 be renewed (B)

Updated on 08 August 2019

File name

ie-spc-clean-de5724-v014_1565270962.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 July 2019

File name

ie-spc-clean-de5724-maht_1562830324.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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)

Updated on 27 February 2019

File name

ie-spc-de5724-v012-clean amended rtq_1551255497.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 26 February 2019

File name

Sirdupla ie-pl-clean-de5724-v012 rtq_2_1551180712.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 22 August 2017

File name

PIL_17203_166.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 August 2017

Reasons for updating

  • Change to name of medicinal product

Updated on 06 July 2017

Reasons for updating

  • New SPC for new product

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

Updated on 30 June 2017

Reasons for updating

  • New PIL for new product