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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: 02/09/2010
SPC Metvix Cream

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 02/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Reduction in shelf-life from 18 months to 15 months.
Updated on 26/08/2008 and displayed until 02/09/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Shelf life of the product has been updated
Updated on 06/08/2008 and displayed until 26/08/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update to section 4.4 and 4.8
Updated on 27/07/2007 and displayed until 06/08/2008
Reasons for adding or updating:
  • Change to marketing authorisation holder address
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change in office address of marketing authorisation holder.
Updated on 08/03/2007 and displayed until 27/07/2007
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

Update of section 4.8 - Undesirable effects

Updated on 10/04/2006 and displayed until 08/03/2007
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
Updated on 19/04/2004 and displayed until 10/04/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
Updated on 15/08/2003 and displayed until 19/04/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 16/06/2003 and displayed until 15/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Methyl Aminolevulinate Hydrochloride

Versions

 
02/09/2010 to Current
26/08/2008 to 02/09/2010
06/08/2008 to 26/08/2008
27/07/2007 to 06/08/2008
08/03/2007 to 27/07/2007
10/04/2006 to 08/03/2007
19/04/2004 to 10/04/2006
15/08/2003 to 19/04/2004
16/06/2003 to 15/08/2003
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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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