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Galderma (U.K) Ltd

Galderma (U.K) Ltd
Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire, WD17 1DS, UK
Telephone: +44 (0) 1923 208950
Fax: +44 (0) 1923 208998
Summary of Product Characteristics last updated on medicines.ie: 10/05/2012
SPC Loceryl Nail Lacquer

When a pharmaceutical company changes an SPC or PIL, 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 10/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   03-May-2012
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 12/08/2010 and displayed until 10/05/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   27-Jul-2010
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 16/04/2009 and displayed until 12/08/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Trade name of the product has been updated in line with current guidelines
Updated on 01/03/2007 and displayed until 16/04/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.8 - Undesirable effects

Updated on 31/08/2006 and displayed until 01/03/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02/2006
Legal Category:   prescription only

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 03/03/2005 and displayed until 31/08/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 15/12/2003 and displayed until 03/03/2005
Reasons for adding or 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
Updated on 13/08/2003 and displayed until 15/12/2003
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/06/2003 and displayed until 13/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Amorolfine Hydrochloride

Versions

 
10/05/2012 to Current
12/08/2010 to 10/05/2012
16/04/2009 to 12/08/2010
01/03/2007 to 16/04/2009
31/08/2006 to 01/03/2007
03/03/2005 to 31/08/2006
15/12/2003 to 03/03/2005
13/08/2003 to 15/12/2003
16/06/2003 to 13/08/2003
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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