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Novartis Ireland Limited

Vista Building, Elm Park Business Park, Merrion Road, Dublin 4, Ireland
Telephone: +353 1 2601255
Fax: +353 1 2601263
Medical Information e-mail: medinfo.dublin@novartis.com
Summary of Product Characteristics last updated on medicines.ie: 19/06/2017
SPC Azopt 10mg/ml eye drops suspension

When a pharmaceutical company changes an SPC or PIL, 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 19/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-May-2017
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 03/09/2014 and displayed until 19/06/2017
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   25-Apr-2014
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 04/06/2014 and displayed until 03/09/2014
Reasons for adding or 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
Date of revision of text on the SPC:   25-Apr-2014
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 31/05/2013 and displayed until 04/06/2014
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   19-Mar-2013
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 07/12/2011 and displayed until 31/05/2013
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   29-Jan-2010
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 18/09/2008 and displayed until 07/12/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.1 (Therapeutic indications) have added 'or prostaglandin analogues'.
Updated on 12/02/2008 and displayed until 18/09/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.3 Updated section to bring in line with current legislation
Updated on 12/07/2005 and displayed until 12/02/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 06/06/2003 and displayed until 12/07/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Brinzolamide