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Almirall Limited

4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK
Telephone: +44 (0) 207 160 2500
Fax: +44 (0) 208 756 3888
WWW: http://www.almirall.com
Medical Information Direct Line: 0800 0087399
Medical Information e-mail: almirall@professionalinformation.co.uk
Customer Care direct line: +44 (0) 207 160 2500
Medical Information Fax: +44 (0) 1748 828 801

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/05/2011
SPC Vaniqa 11.5% cream

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 09/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   04-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

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 - Information on frequency updated
Section 6.6 - Any unused product or waste material should be disposed of in accordance with local requirements
Updated on 13/10/2010 and displayed until 09/05/2011
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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The MAH has been amended from 'Laboritorios Almirall, S.A.' to 'Almirall, S.A.'
Updated on 03/12/2009 and displayed until 13/10/2010
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:   POM
Black Triangle (CHM):   NO

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 17/12/2008 and displayed until 03/12/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   25-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of the Black Triangle
Updated on 26/09/2008 and displayed until 17/12/2008
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

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

Active Ingredients/Generics

 
  eflornithine hydrochloride monohydrate