Desunin 800IU Tablets

*
Pharmacy Only: Prescription
  • Company:

    Mylan IRE Healthcare Ltd
  • Status:

    No Recent Update
  • Legal 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 03 July 2023

File name

ie-pl-se1122-800iu-ws615_maht-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 03 July 2023

File name

ie-spc-se1122-800iu-ws615_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 03 July 2023

File name

ie-pl-se1122-800iu-ws615_maht-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 03 July 2023

File name

ie-spc-se1122-800iu-ws615_maht-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 28 January 2021

File name

ie-spc-se1122-800iu-v017-clean-rtq.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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)

Updated on 28 January 2021

File name

ie-pl-se1122-800iu-v017-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 - what the product contains
  • Change to section 6 - date of revision

Updated on 22 March 2019

File name

ie-pl-se1122-800iu-mahtransfer-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 March 2019

File name

ie-spc-se1122-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 15 May 2017

Reasons for updating

  • New SPC for new product

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

Updated on 15 May 2017

Reasons for updating

  • 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 15 May 2017

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 10: date of revision has changed

Updated on 13 July 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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 1: Slight text amendment

In section 4.1: Further text added to the therapeutic indications.

In section 4.2: Change in information for posology.

In section 4.4: Removal of text as it is moved to section 4.2

In section 4.8: Addition of ADR statement.

In section 5.3: Minor typographical correction.

In section 6.1: Change in description of one of the excipients.

In section 10: The date of revision has been changed.

Updated on 13 July 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 1: Slight text amendment

In section 4.1: Further text added to the therapeutic indications.

In section 4.2: Change in information for posology.

In section 4.4: Removal of text as it is moved to section 4.2

In section 4.8: Addition of ADR statement.

In section 5.3: Minor typographical correction.

In section 6.1: Change in description of one of the excipients.

In section 10: The date of revision has been changed.

Updated on 08 September 2014

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 storage conditions have changed from ‘Do not store above 25°C’ to ‘Do not store above 30°C’.

In section 10: the date of revision has changed.

Updated on 08 September 2014

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.4: the storage conditions have changed from ‘Do not store above 25°C’ to ‘Do not store above 30°C’.

In section 10: the date of revision has changed.

Updated on 10 June 2014

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: the shelf life has increased to 3 years from 2 years
In section 10: the date of revision has changed to June 2014

Updated on 10 June 2014

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.3: the shelf life has increased to 3 years from 2 years
In section 10: the date of revision has changed to June 2014

Updated on 18 July 2013

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: The shelf-life of Desunin has been extended from 18 months to 2 years.

In section 10: The date of revision has been changed.

Updated on 18 July 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.3: The shelf-life of Desunin has been extended from 18 months to 2 years.

In section 10: The date of revision has been changed.

Updated on 06 November 2012

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

Updated on 06 November 2012

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided