Dymista Nasal Spray *
Company:
Mylan IRE Healthcare LimitedStatus:
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
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 07 December 2020
File name
ie-spc-de3355-v035v038-clean_1607358601.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_1607358559.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_1597418833.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_1559038560.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_1551803637.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
- 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 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 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)