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Loceryl Nail Lacquer

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Pharmacy Only: Prescription
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Updated on 10 July 2023

File name

(23300) P23283-12 LOCERYL 5 APP SOL 5 IRL LEAFLET.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

  • PIL updated to remove watermark

Updated on 09 May 2023

File name

ie-spc-clean Loceryl Nail Lacquer.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 May 2023

File name

ie-spc-current-Loceryl-May19.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 February 2020

File name

ie-spc-current-Loceryl-May19.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
  • File format updated to PDF

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 July 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 July 2017

Reasons for updating

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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: Warning regarding systemic or local allergic reactions
Section 4.8; ADR Hypersensitivity (systemic allergic reaction)
Section 10: Date of revision

Updated on 20 June 2017

File name

PIL_9128_724.pdf

Reasons for updating

  • New PIL for new product

Updated on 20 June 2017

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 14 October 2015

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Packaging format updated with new applicator option.

Updated on 14 October 2015

Reasons for updating

  • Change to packaging

Updated on 24 October 2013

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.3 (contra-indications), information about the use of Loceryl Nail Lacquer during pregnancy has been removed.
In section 4.4 (special warnings), information about the use of Loceryl Nail Lacquer in children has been added as well as information about the use of cosmetic nail lacquer and artificial nails.
In section 4.8 (undesirable effects), erythema, pruritus, contact dermatitis, urticaria and blister have been listed as side effects with an unknown frequency.

The SPC has also been updated in line with QRD.

Updated on 24 October 2013

Reasons for updating

  • Change to side-effects

Updated on 02 August 2012

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 10 May 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Additional warning added to section 4.4 to advise that product should not be applied to the nail bed.

Updated on 11 November 2010

Reasons for updating

  • Change to side-effects
  • Improved electronic presentation

Updated on 12 August 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 of the SPC has been updated to include additional information about the type of undesirbale effects that can be seen with Loceryl Nail Lacquer.

Updated on 24 June 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 16 April 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Trade name of the product has been updated in line with current guidelines

Updated on 19 March 2007

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 01 March 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 - Undesirable effects

Updated on 31 August 2006

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 – Change of office address from Galderma House, Church Lane, Kings Langley, Hertfordshire, WD4 8JP to Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS

Updated on 16 May 2005

Reasons for updating

  • Change of manufacturer
  • Change to date of revision
  • Change of inactive ingredient

Updated on 03 March 2005

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 December 2003

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • 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 be renewed (B)

Updated on 13 August 2003

Reasons for updating

  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

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

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