Iopidine 5mg/ml Eye Drops Solution

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Iopidine 5mg/ml Eye Drops Solution

Name:
Iopidine 5mg/ml Eye Drops Solution
Company:
Novartis Ireland Limited
Active Ingredients:
Apraclonidine Hydrochloride
Legal Category:
Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/04/19

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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 29 August 2019 SmPC

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)

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 SmPC

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

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

Marketing authorisation transfer

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

- Sections 7,8 and 10 updated following approval of change of ownership.

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 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 SmPC

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

- better format of date of revision

Updated on 7 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

- MAH address change and date of revision

Updated on 2 May 2014 PIL

Reasons for updating

Change to MA holder contact details

Updated on 16 December 2011 SmPC

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 SmPC

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 2, Qualitative and quantitative composition, ‘For excipients, see section 6.1.’ is replaced by ‘For a full list of excipients, see section 6.1.’

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)