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: 08/01/2010
SPC Piriteze Allergy Tablets (P)

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 08/01/2010 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:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



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

Updated on 22/06/2009 and displayed until 08/01/2010
Reasons for adding or updating:
  • Extra statutory information
Date of revision of text on the SPC:   17-Mar-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The licence now has unlimited expiry.
Updated on 15/05/2008 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:   04-Apr-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 6.5 (nature and contents of container), the 7 pack size has been removed
Updated on 22/10/2007 and displayed until 15/05/2008
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 10 date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.1 Addition of "in adults and children aged 6 years and over"
Section 4.2 Dosing changed from adults and children over 12 to adults and children aged 6 years and over.  Addition of statement "Not for use by children under 6 years of age"
Section 10 Updated
Updated on 19/06/2007 and displayed until 22/10/2007
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