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Curanail 5% w/v Medicated Nail Lacquer

  • Name:

    Curanail 5% w/v Medicated Nail Lacquer

  • Company:
    info
  • Active Ingredients:

    Amorolfine Hydrochloride

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/06/18

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 13/6/2019

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Galderma International S.A.S. c/o Galderma (U.K) Ltd.

Galderma (U

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1 - 0 of 18 items.Total: Infinity pages

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 13 June 2019 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: Supply through pharmacy only

Updated on 29 June 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 6 June 2018

Updated on 5 June 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 9 May 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 2 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 2 February 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

  • Section 4.4: addition of the following: 'A systemic or local allergic reaction could possibly occur after use of this product. If this happens, the product should be stopped immediately and medical advice should be sought. Remove the product carefully by using a nail remover solution. The product should not be reapplied.'
  • Section 4.8: Change in the following: 'Adverse drug reactions are were rare in clinical trials.' Also, slight changes to the wording of text in the table.
  • Section 6.5: Addition of '2.5ml-glass bottle with accessories (30 nail files, 30 cleaning swabs, 30 applicators).
  • Section 10: Change in the date of revision to 'December 2017'.

Updated on 14 October 2016 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of new applicator cap

Updated on 11 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 October 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 25 July 2016 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 25 July 2016 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of a 1.25ml pack size.

Updated on 7 September 2015 PIL

Reasons for updating

  • Change to packaging

Updated on 13 April 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Renewal of the Marketing authorization and variation to update section 6.3 of the SPC and section 5 of the PIL as the in-use stability data provided allows proposing  a Shelf life after first opening of 6 months

Updated on 2 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 30 April 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation

Updated on 28 April 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Information on how to report adverse events has been added to section 4.8

The SPC has been updated in line with the QRD.

Warning regarding the use of organic solvents has been added to section 4.4

Updated on 19 November 2013 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 5.3 - Preclinical safety data
  • Change to improve clarity and readability

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 3, information on the appearance of the nail lacquer has been added.
Some additional information has been added to section 5.3.
The overall readability of the SPC has also been improved.

Updated on 18 November 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 30 April 2012 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 April 2012 PIL

Reasons for updating

  • New PIL for new product