Dymista Nasal Spray

Product Information *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 6.4: The shelf-life of 6.4g presentation has been extended to 1 year
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 6.3: reduction of shelf-life for the 23g pack size
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

Section 4.1: the spelling for glucocorticoid was wrong and this is now corrected

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

None provided