SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension
*Company:
Novartis Ireland 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
Updated on 17 July 2024
File name
Simbrinza_REG PIL_PF23-0012_10.12,2022_Deletion of UK(NI)_July 2024.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Removal of information for UK(NI)
Updated on 21 December 2022
File name
Simbrinza_REG SPC_PF22-0111_10.12.2022_clean_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 December 2022
File name
Simbrinza_REG PIL_PF22-0111_10.12.2022_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 12 October 2021
File name
Simbrinza REGPIL_PF21-0061_TBI 26 June 2022_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 25 August 2021
File name
Simbrinza REG PIL_R89 pack_PF20-0209 with corrections 2021.pdf
Reasons for updating
- Change to MA holder contact details
- Change of manufacturer
Updated on 12 October 2020
File name
Simbrinza REG PIL PF 19-0044 FEB 2019IPHA.pdf
Reasons for updating
- Change to other sources of information section
Updated on 02 January 2020
File name
Simbrinza REG SPC PF 20-0001 Nov 2019 clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 October 2019
File name
Simbrinza REG SPC PF 19-0123 October 2019 clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 29 August 2019
File name
Simbrinza REG PIL PF 19-0044 FEB 2019.pdf
Reasons for updating
- Change to date of revision
Updated on 29 April 2019
File name
CP__Simbrinza_PIL PF 19-0044.pdf
Reasons for updating
- Change to date of revision
Updated on 11 April 2019
File name
CP__Simbrinza_PIL PF 19-0044.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 08 April 2019
File name
REG_SmPC Simbrinza_0.2-1%_EyDrpSusp_20-Feb-19__Clean PF19-0044PDF.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change in SmPC following renewal of the Marketing authorisation
Updated on 14 March 2019
File name
CP__Simbrinza_PIL PF 19-0044.pdf
Reasons for updating
- Change to date of revision
Updated on 29 May 2018
File name
SimbrinzaSmPCPF18-0101.docx
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Adress change for the MAH from UK to Ireland
Updated on 30 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 May 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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 19 May 2017
File name
PIL_16061_852.pdf
Reasons for updating
- New PIL for new product
Updated on 19 May 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 03 August 2015
Reasons for updating
- Improved electronic presentation
Updated on 23 June 2015
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 June 2015
Reasons for updating
- Change to MA holder contact details
Updated on 07 August 2014
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 01 August 2014
Reasons for updating
- New PIL for new product