Sirdupla 25 microgram/125 microgram, 25 microgram/250 microgram per metered dose pressurised inhalation, suspension
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 February 2025
File name
ie-pl-de5724-Art 61.3-clean (MD).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 04 April 2024
File name
ie-pl-clean-de5724-maht_clean_Sirdupla 25mcg_125mcg.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 04 April 2024
File name
ie-spc-clean-de5724-maht_clean_Sirdupla 25mcg_125mcg.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 28 August 2023
File name
ie-pl-clean-de5724-v028.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.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.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.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.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.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.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.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.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.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
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1