Iopidine 1% Eye Drops Solution
- Name:
Iopidine 1% Eye Drops Solution
- Company:
Novartis Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/03/19
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Novartis Ireland Limited
Company Products
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 16 September 2019 SmPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to date of revision
Updated on 6 September 2018 SmPC
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 11 July 2018 SmPC
Reasons for updating
- Addition of marketing authorisation holder
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 July 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 July 2018 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
MAH Transfer
Updated on 11 June 2018 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated safety information
Updated on 7 June 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
Updated on 30 May 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 30 May 2017 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 18 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 18 May 2017 PIL
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 7 July 2016 SmPC
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 6 July 2016 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 13 May 2014 SmPC
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 2 May 2014 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 18 December 2012 PIL
Reasons for updating
- Improved electronic presentation
Updated on 13 August 2010 SmPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6 - Section amended to include there is no adequate data from the use of Iopidine in pregnant women, and caution should be exercised when Iopidine is administered to nursing women.
Section 4.8 - Section updated to MEDRA coding.
Section 4.9 - Information on overdosage in a 2month old child has been added.
Section 6.1 - 'Preservative Free' removed.
Section 6.4 - 'In order to protect from light' removed.
Section 6.5 - Additional pack sizes included.
Section 10 - Date of revision changed to July 2006.
Updated on 12 August 2010 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 13 August 2007 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 13 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)