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LEO Pharma
Cashel Road, Dublin 12,
Telephone: +353 1 490 8924
Fax: +353 1 708 2054
Medical Information e-mail: medical-info.ie@leo-pharma.com
Medical Information Facsimile: +353 1 708 2089
Summary of Product Characteristics last updated on medicines.ie: 29/08/2011
SPC Fucibet 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 29/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Jul-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 6.1 List of excipinets. The following excipient has been added:

all-rac-α-tocopherol

Section 10. Date of (Partial) revision of the text. UPdated to:

July 2011
Updated on 09/02/2011 and displayed until 29/08/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Dec-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 3. Pharmaceutical form

Cream

A white to off white homogenous cream

 

Section 6.3 Shelf life

3 years

After first opening of container: 3 months

 

Section 6.4 Special precautions for storage

Store below 30°cThis medicinal product does not require any special storage conditions

 

Section 10. Date of (Partial) Revision of the text

November 2009December 2010
Updated on 08/09/2010 and displayed until 09/02/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   16-Aug-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In section 2, the quantity of the excipients has been added.
Updated on 06/08/2009 and displayed until 08/09/2010
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   10-Jul-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 2 quantitative composition declaration
Section 6.1 'for pH adjustment' added after sodium hydroxide
Section 6.4 updated as per guideline
Section 6.5 sample pack and sentence 'Not all pack sizes may be marketed' added
Section 10 revised to 10th July 2009
Updated on 24/11/2008 and displayed until 06/08/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Safety sections of SPC (4.3, 4.4, 4.6 & 4.8) updated in line with updated Company Core Safety Information.
Updated on 09/01/2007 and displayed until 24/11/2008
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 10. Date revised to December 2006
Updated on 20/07/2006 and displayed until 09/01/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 10 - date changed (Part 1 of PA revised)
Updated on 19/07/2005 and displayed until 20/07/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
Updated on 23/02/2005 and displayed until 19/07/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 4.9 - Overdose
Updated on 02/02/2005 and displayed until 23/02/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Updated on 20/07/2004 and displayed until 02/02/2005
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Updated on 26/06/2003 and displayed until 20/07/2004
Reasons for adding or updating:
  • Addition of legal category
Updated on 26/06/2003 and displayed until 26/06/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
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