Iopidine 5mg/ml Eye Drops Solution *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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

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

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

- better format of date of revision

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

- MAH address change and date of revision

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 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

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)