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Almirall Limited

4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK
Telephone: +44 (0) 1256 698 037
Fax: +44 (0) 1256 698 237
WWW: http://www.almirall.com
Medical Information Direct Line: +44 (0)1748 828 795
Medical Information e-mail: almirall@professionalinformation.co.uk.
Medical Information Facsimile: +44 (0) 1748 828 801
Summary of Product Characteristics last updated on medicines.ie: 11/07/2011
SPC Vaniqa 11.5% 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 11/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   04-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2 - Quantities of excipients added
Section 4.1 - Reference to female adolescents and adult women added
Section 4.2 - Reworded
Section 4.4 - Reference to the potential for methyl parahydroxybenzoate and propyl parahydroxybenzoate to cause allergic reactions added
Section 4.6 - Information on fertility added
Section 4.7 - Vaniqa has no or negligable effects on the ability to drive and use machines
Section 4.8 - Frequency information updated
Section 6.6 - Any unused product or waste material should be disposed of in accordance with local requirements
Updated on 14/10/2010 and displayed until 11/07/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
MAH contact details have been changed from 'Laboratorios Almirall, S.A.' to 'Almirall, S.A.'
Updated on 04/12/2009 and displayed until 14/10/2010
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:   25-Nov-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 6.1 (list of excipients), "sodium hydroxide (E524) (to adjust pH) has been added.
Updated on 01/09/2009 and displayed until 04/12/2009
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
None provided

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Active Ingredients

 
  Eflornithine hydrochloride monohydrate