Vitaros 3mg/g Cream
*Company:
Recordati Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 06 December 2023
File name
ie-pl-3mg-clean[1].pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - marketing authorisation holder
Updated on 06 December 2023
File name
ie-spc-3mg-clean[1].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 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2023
File name
ie-pl-vitaros-january2022.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 17 February 2023
File name
ie-spc-vitaros-january2022.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 February 2022
File name
vitaros-3mg_g-spc.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Chnage to section 6.3 - shelf life extended to 14 months
Updated on 26 June 2020
File name
131-spc-3mg_IE_clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2018
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 6.3, the shelf life has been reduced from 18 months to 12 months.
Updated on 08 September 2017
File name
PIL_16843_371.pdf
Reasons for updating
- New PIL for new product
Updated on 08 September 2017
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 August 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 August 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 18 August 2017
Reasons for updating
- Change to section 3 - how to take/use
Updated on 05 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 August 2016
Reasons for updating
- New PIL for new product