Desunin 800IU Tablets
*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 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
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
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 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 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
Updated on 06 November 2012
Reasons for updating
- New SPC for new product