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Leo Laboratories Limited
Longwick Road, Princes Risborough, Bucks., HP27 9RR
Telephone: +44 (0)1844 347 333
Fax: +44 (0)1844 276 385
Medical Information e-mail: medical-info.uk@leo-pharma.com

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: 16/04/2012
SPC Xamiol gel

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 16/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • In section 7, the name of the Marketing Authorisation Holder has been changed from LEO Pharmaceutical Products Ltd., A/S to LEO Pharma A/S
  • In section 10, the date of revision of the text has been updated
Updated on 28/07/2011 and displayed until 16/04/2012
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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   11-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 4.2 - Posology and method of administration
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
Change to Section 5.1 - Pharmacodynamic properties
Change to Section 5.2 - Pharmacokinetic properties
Change to Section 5.3 - Preclinical data
Updated on 03/11/2008 and displayed until 28/07/2011
Reasons for adding or updating:
  • New SPC for new product
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

 
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