Nevanac 1mg/ml eye drops, suspension

*
Pharmacy Only: Prescription
  • Company:

    Novartis Ireland Limited
  • 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 09 July 2024

File name

Nevanac 1mg_ml_REG PIL_Removal of UK(NI)_May 2024_clean.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) from leaflet

Updated on 23 November 2023

File name

Nevanac 1mg_ml_REG SPC_PF23-0200_11.11.2023_clean_IPHA.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Updated on 23 November 2023

File name

Nevanac 1mg_ml_REG SPC_PF23-0200_11.11.2023_clean_IPHA.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Updated on 23 November 2023

File name

Nevanac 1mg_ml_REG SPC_PF23-0200_11.11.2023_clean_IPHA.pdf

Reasons for updating

  • Updated inline with QRD template and/or excipient guideline

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

Updated on 23 November 2023

File name

Nevanac 1mg_ml_REG PIL_PF23-0200_11.11.2023_clean_IPHA.pdf

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Correction of spelling/typing errors

Updated on 25 January 2022

File name

Nevanac_1mg-ml_REG PIL_PF21-0227_clean_typo corrected_TBI 31.03.2022.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 03 November 2021

File name

Nevanac 1mg_ml_REG SPC_PF21-0227_clean.pdf

Reasons for updating

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

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

Updated on 03 November 2021

File name

Nevanac_1mg-ml_REG PIL_PF21-0227_clean_TBI 31.03.2022.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to MA holder contact details

Updated on 12 October 2020

File name

PIL Nevanac 1mg-ml eye drops suspension PF 20-0083 IPHA.pdf

Reasons for updating

  • New individual PIL (was previously included in a combined PIL)

Updated on 11 December 2019

File name

Nevanac 1mgml REG PIL 758850 TBI 06-02-2019 IPHA.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 11 April 2019

File name

Nevanac1mgmlSmPCPF18-0115_IPHA.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 08 April 2019

File name

Nevanac1mgmlSmPCPF18-0115_IPHA.pdf

Reasons for updating

  • File format updated to PDF

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

Updated on 14 November 2018

File name

Nevanac 1mml_758850___LFT_IPHA.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 May 2018

File name

Nevanac1mgmlSmPCPF18-0115.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Adress for the MAH has now been updated

Updated on 06 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 06 June 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

- Following approval of transfer for Marketing authorisation from Alcon to Novartis.

Updated on 01 June 2017

File name

PIL_14754_945.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 June 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 20 October 2016

Reasons for updating

  • Improved presentation of PIL

Updated on 22 September 2016

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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

-Sections 4.3 and 4.8 have been updated.
-A minor change has been made to section 5.2 of the SmPC.

-This SmPC was re-uploaded to medicines.ie due to duplicate SmPC entries on the website.

Updated on 08 August 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision

Updated on 12 June 2015

Reasons for updating

  • Improved electronic presentation

Updated on 19 May 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Section 4.8 - added corneal perforation as an adverse event 

Updated on 06 May 2015

Reasons for updating

  • Change to side-effects

Updated on 09 October 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.8 - Updated Irish autority contact information

Updated on 25 September 2014

Reasons for updating

  • SPC re-instated

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

Free text change information supplied by the pharmaceutical company

SPC re-instated

Updated on 19 August 2014

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 07 January 2014

Reasons for updating

  • Improved electronic presentation

Updated on 09 October 2012

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 12 August 2010

Reasons for updating

  • PIL - Product no longer marketed in Ireland
  • New PIL for medicines.ie

Updated on 13 October 2009

Reasons for updating

  • New SPC for medicines.ie
  • Product no longer marketed in Ireland

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

Free text change information supplied by the pharmaceutical company

None provided