Nevanac 1mg/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 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
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
-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
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
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
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)