Iopidine 5mg/ml Eye Drops Solution
Product Information *
Company:
Novartis Ireland LimitedStatus:
No Recent UpdateActive Ingredients :
*Additional information is available upon request
Legal Category:
Product subject to medical prescription which may not be renewed (A)
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 28 January 2021
File name
Iopidine_5mgml_REG SPC_January 2021_Clean_IPHA_1611840109.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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)
Updated on 28 January 2021
File name
License_PIL_8ae1fdb6-eff3-4e2b-bd8e-c7b02af8bede_1611839978.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 02 March 2020
File name
iopidine 5mgml REG PIL PF 19-0250 Clean IPHA_1583151431.pdf
Reasons for updating
- Addition of marketing authorisation holder
Updated on 20 January 2020
File name
Iopidine 5mgml REG PIL PF 18-0168 IPHA_1579534707.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 16 September 2019
File name
REG_SPC_iopidine5mgml_PF20170239and PF 18-0168clean_1568619043.pdf
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
File name
IE-NPI-ENG-Iopidine 5 mg_ml_%_eye drops_29-06-2018_(clean)_1567076379.pdf
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
File name
IPHA756122_R92_p2_LFT_X-4TBI jan 2019_1554888622.pdf
Reasons for updating
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 25 March 2019
File name
IPHA431205_R92_p1_LFT_TBI jan 2019_1553525466.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 20 August 2018
File name
REG_SPC_iopidine5mgml_PF20170239_clean_1534761010.pdf
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 09 July 2018
File name
REG_SPC_Iopidine5mg-ml_PF18-168clean.docx
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
- 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 30 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 May 2017
File name
PIL_8790_31.pdf
Reasons for updating
- New PIL for new product
Updated on 18 May 2017
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
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 07 May 2014
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 02 May 2014
Reasons for updating
- Change to MA holder contact details
Updated on 16 December 2011
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
Reasons for updating
- Change due to harmonisation of PIL
Updated on 01 March 2011
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
Reasons for updating
- Change due to harmonisation of PIL
Updated on 13 August 2010
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
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 May 2005
Reasons for updating
- Improved electronic presentation
Updated on 10 September 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 12 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)