SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension

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Pharmacy Only: Prescription

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

- Updates to section 7,8 and 10 following change of ownership from Alcon to Novartis.

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

Section 5.1 - Added ATC code information

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

None provided

Updated on 01 August 2014

Reasons for updating

  • New PIL for new product