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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: 28/11/2011
SPC Balneum Plus Bath Oil

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 28/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   17-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
updated section 4.3 of the SmPCs with the soya warning as per the Excipients Guideline dated July 2003
Updated on 19/07/2010 and displayed until 28/11/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • Section 7 – name of the MAH has changed to Almirall Hermal GmbH
  • Section 8 – PL number has changed
  • Section 10 – revision date has changed
    • Updated on 02/11/2009 and displayed until 19/07/2010
    Reasons for adding or updating:
    • Change to section 10 date of revision of the text
    • Introduction of new pack/pack size
    Date of revision of text on the SPC:   08-Oct-2009
    Legal Category:   POM
    Black Triangle (CHM):   NO

    Free-text change information supplied by the pharmaceutical company
    Addition of a bundle pack size of 2 x 500ml to the licence.
    Updated on 26/09/2008 and displayed until 02/11/2009
    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):   NO

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

    Active Ingredients/Generics

     
      lauromacrogols
      soya oil