GlaxoSmithKline Consumer Healthcare

980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700
Medical Information Fax: +44 (0)20 8047 6860

Summary of Product Characteristics last updated on the eMC: 19/01/2010
SPC Piriteze Allergy Tablets (GSL)

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 19/01/2010 and displayed until Current
Reasons for adding or updating:
  • Extra statutory information
Date of revision of text on the SPC:   24-Nov-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



The Piriteze  (GSL) SPC has been updated inorder to align with Article 30 harmonisation referral for Zyrtec.

Updated on 22/06/2009 and displayed until 19/01/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   22-Apr-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 6.5, a new pack size 12 has been added.
Updated on 21/10/2008 and displayed until 22/06/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Jul-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 6.5 - addition of a pack size of 12
Updated on 03/07/2008 and displayed until 21/10/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   08-Aug-2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

To amend sections 4.1 and 4.2 to include children aged 6 years and over.
Addition of pack size 14 to section 6.5
Updated on 24/07/2007 and displayed until 03/07/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   06/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - updated to include a specific lactose excipient warning
Updated on 19/06/2007 and displayed until 24/07/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   cetirizine hydrochloride