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UCB Pharma Limited
208 Bath Road, Slough, Berkshire, SL1 3WE
Telephone: +44 (0)1753 534 655
Medical Information Direct Line: +44 (0)1753 447 690
Medical Information e-mail: Medicalinformationuk@ucb.com
Customer Care direct line: +44 (0) 1773 510123

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: 15/07/2011
SPC Xyzal 5mg Tablets

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 15/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   20-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The following wordinghas been approved by the MHRA for addition to Section 4.1 of the SmPC:

 Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria.

 And for 5.1:

 Chronic idiopathic urticaria was studied as a model for urticarial conditions.  Since histamine release is a causal factor in urticarial diseases, levocetirizine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria.

Updated on 14/06/2005 and displayed until 15/07/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Pending awaiting re-submission
Updated on 27/05/2005 and displayed until 14/06/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.8 - Undesirable Effects
  • Correction of spelling/typing errors
Updated on 20/12/2004 and displayed until 27/05/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Black Triangle
Updated on 17/12/2004 and displayed until 20/12/2004
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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Pending awaiting re-submission
Updated on 11/11/2002 and displayed until 17/12/2004
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/10/2001 and displayed until 11/11/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  levocetirizine dihydrochloride