Curanail 5% w/v Medicated Nail Lacquer *
Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive 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 20 April 2020
File name
Curanail 2.5ml PIL IRE V7 (P26938-3)_1587377896.pdf
Reasons for updating
- Change to marketing authorisation holder
Updated on 09 February 2020
File name
ie-spc-current-Curanail-May19_1581287532.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Supply through pharmacy only
Updated on 13 June 2019
File name
Curanail SPC_1560442635.pdf
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
File name
Curanail 2.5ml PIL IRE (P26938-2) eMC.pdf
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
File name
Curanail 2.5ml PIL IRE (P26938-1) eMC.pdf
Updated on 05 June 2018
File name
Curanail IRE SPC V9.doc
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 09 May 2018
File name
Curanail 2.5ml PIL IRE (P26938-1) eMC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 02 February 2018
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
arewere 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 02 February 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 14 October 2016
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
File name
PIL_15355_967.pdf
Reasons for updating
- New PIL for new product
Updated on 11 October 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 25 July 2016
Reasons for updating
- Introduction of new pack/pack size
Updated on 25 July 2016
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 07 September 2015
Reasons for updating
- Change to packaging
Updated on 13 April 2015
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 02 April 2015
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
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
Updated on 28 April 2014
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
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
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.
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
Reasons for updating
- Correction of spelling/typing errors
- Improved electronic presentation
Updated on 30 April 2012
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
Reasons for updating
- New PIL for new product