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

Updated on 28 August 2023

File name

64ec5231cb44c.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product

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