Dymista Nasal Spray
*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 09 September 2024
File name
ie-pl-de3355-v045-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 03 July 2023
File name
ie-pl-de3355-MAHT-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 03 July 2023
File name
ie-spc-de3355-MAHT-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 April 2022
File name
ie-pl-de3355-v040-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 07 December 2020
File name
ie-spc-de3355-v035v038-clean.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 07 December 2020
File name
ie-pl-de3355-v038-clean-rtq.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 14 August 2020
File name
ie-spc-de3355-v035-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 28 May 2019
File name
ie-pl-de3355-art613andmahtransfer-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 05 March 2019
File name
PIL_15793_521.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 05 March 2019
File name
ie-spc-de3355-mahtransfer-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 May 2018
File name
Dymista_Nasal_Spray_SmPC_May_2018.docx
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)
Free text change information supplied by the pharmaceutical company
In section 6.3: change in shelf-life
In section 10: date of revision changed
Updated on 09 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 November 2017
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 10: The date of revision has changed
Updated on 21 July 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.5: Information added regarding co-treatment with other CYP 3A4 inhibitors, and expectancy to increase the risk of systemic side-effects.
In section 10: Date of revision changed.
Updated on 27 June 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4: Information regarding visual disturbance has been added.
In section 4.8: Blurred vision has been added to undesirable effects with frequency of not known
In section 10: The date of revision has been changed.
Updated on 18 August 2015
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)
Free text change information supplied by the pharmaceutical company
In section 10: date of revision has changed
Updated on 27 January 2015
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)
Free text change information supplied by the pharmaceutical company
In section 4.8: Adverse reaction reporting statement has been added
In section 10: date of revision has changed
Updated on 24 October 2014
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 July 2013
File name
PIL_15793_521.pdf
Reasons for updating
- New PIL for new product
Updated on 17 April 2013
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
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