Azopt 10mg/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 30 March 2023
File name
AZOPT_REG PIL_PF23-0071_March2023_clean_IPHA .pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 30 March 2023
File name
AZOPT_REG SPC_PF23-0017_March2023_IPHA.pdf
Reasons for updating
- 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 05 July 2022
File name
AZOPT_REG SPC_PF22-0125_24.06.2022_cleanIPHA.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 05 July 2022
File name
AZOPT_REG PIL_PF22-0125_June_2022_IPHA.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 03 November 2021
File name
Azopt REG PIL_IPHA_PF21-0091_IE_NI.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 10 December 2019
File name
Azopt REG PIL 669990 PF19-0148 IPHA.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 23 July 2019
File name
669990_R89_p3_LFT_RegREV10-5-2019 IPHA.pdf
Reasons for updating
- Addition of manufacturer
Updated on 23 July 2019
File name
Azopt_eye_dropsREGSPC_PF18-0099-updated.pdf
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)
Updated on 08 April 2019
File name
Azopt_PF18-0099_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
Azopt_759000_IPHA_TBI 9 feb 2019.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 16 May 2018
File name
Azopt_PF18-0099.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 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 15 June 2017
File name
PIL_8759_341.pdf
Reasons for updating
- New PIL for new product
Updated on 15 June 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 06 March 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 03 September 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 28 August 2014
Reasons for updating
- Improved electronic presentation
Updated on 04 June 2014
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 29 May 2014
Reasons for updating
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
Updated on 14 August 2013
Reasons for updating
- Improved electronic presentation
Updated on 16 July 2013
Reasons for updating
- Change to MA holder contact details
Updated on 31 May 2013
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
Updated on 29 May 2013
Reasons for updating
- Change to marketing authorisation holder
Updated on 07 December 2011
Reasons for updating
- Change due to harmonisation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 August 2010
Reasons for updating
- Change due to harmonisation of PIL
Updated on 18 September 2008
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 12 February 2008
Reasons for updating
- Change to section 4.3 - Contraindications
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 July 2005
Reasons for updating
- Improved electronic presentation
Updated on 12 July 2005
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 06 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Novartis Ireland Limited
Address:
Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, IrelandMedical Information E-mail:
medinfo.dublin@novartis.comTelephone:
+353 1 2601255Fax:
+353 1 2601263