Azopt 10mg/ml eye drops suspension *

  • 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 December 2019

File name

Azopt REG PIL 669990 PF19-0148 IPHA_1575999001.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 23 July 2019

File name

669990_R89_p3_LFT_RegREV10-5-2019 IPHA_1563876153.pdf

Reasons for updating

  • Addition of manufacturer

Updated on 23 July 2019

File name

Azopt_eye_dropsREGSPC_PF18-0099-updated_1563874379.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_1554726955.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_1542189398.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

- Update to the SPC following the approval of the change of ownership from Alcon to Novartis.

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 HPRA name and address.

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 product information with CCSI and QRD v.9.

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

MAH address update

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

Changes to section 2, 3, 4.2, 4.4, 4.6, 4.7, 4.8 and 5.3.

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

Section 4.1 (Therapeutic indications) have added 'or prostaglandin analogues'.

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

4.3 Updated section to bring in line with current legislation

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)