Iopidine 5mg/ml Eye Drops Solution
- Name:
Iopidine 5mg/ml 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: 02/03/20
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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 2 March 2020 PIL
Reasons for updating
- Addition of marketing authorisation holder
Updated on 20 January 2020 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2019
Reasons for updating
- Correction of spelling/typing errors
Updated on 29 August 2019
Reasons for updating
- Change to section 10 - Date of revision of the text
Updated on 10 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 25 March 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 August 2018
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Updated on 9 July 2018
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
Marketing authorisation transfer
Updated on 30 May 2017
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 SPC
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 13 May 2014 SPC
Reasons for updating
- 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 7 May 2014 SPC
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 16 December 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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
Sec 2, 4.1 : rewording (mainly removal of 5mg/ml)
Sec 4.2: replacement of a statement and rewording.
4.3: removal of 5mg/ml
4.4: rewording and removal of 5mg/ml; addition of new statement “avoid contact with soft contact lenses”
Sec4.5: addition of two new statement at the start and end of the section
Sec 4.6: amendment as per QRD template
Sec4.7: rewording
Sec4.8: rewriting to be in line with QRD and MedRA classification
Sec 4.9: slight amendment: addition of “lukewarm”
Sec 5.1: rewording
Sec 6.1: amendment of text
6.3: rewording
6.4: rewording and replacement of “moisture” with “light”
Sec 6.6 and 8: change in the title
Sec 9 : addition of renewal date
Sec 10: date revision
Updated on 12 December 2011 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 1 March 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- 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
In Section 6.1, List of excipients, 0.1mg/ml is added against Benzalkonium Chloride.
In Section 9, Date of first authorisation/ renewal of authorisation, the date of last renewal is updated.
In Section 10, Date of revision of the text, the date of revision is updated.
Updated on 28 February 2011 PIL
Reasons for updating
- Change due to harmonisation of PIL
Updated on 13 August 2010 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- 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 9 and Section 10 - dates updated.
Updated on 19 May 2005 SPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 May 2005 PIL
Reasons for updating
- Improved electronic presentation
Updated on 10 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 12 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)