Aspen

12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
Telephone: + 44 1748 828 391
Medical Information Direct Line: 0800 0087 392
Medical Information e-mail: aspenglobal@professionalinformation.co.uk

Summary of Product Characteristics last updated on the eMC: 15/04/2011
SPC Zyloric Tablets 100mg, 300mg

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 15/04/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The Date of Revision of Text
Updated on 26/04/2010 and displayed until 15/04/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   16-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

section 7 change to marketing authorisation holder
Updated on 16/10/2009 and displayed until 26/04/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

section 4.4 - Inclusion of Stevens-Johnson syndrome and toxic epidermal necrolysis

section 4.8 -Inclusion of Stevens-Johnson syndrome and toxic epidermal necrolysis under Skin and subcutaneous tissue disorders section. Paragraph included on HLA-B*5801 allele

section 10 - Date changed to 13 October 2009
Updated on 11/06/2009 and displayed until 16/10/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   04-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.4 - Updated this section of the SmPC with lactose excipient warning. consequential update to section 2 of the PIL.

Updated on 26/09/2006 and displayed until 11/06/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 22/05/2006 and displayed until 26/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   22/05/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441

Updated on 08/02/2005 and displayed until 22/05/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 22/10/2004 and displayed until 08/02/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 26/04/2004 and displayed until 22/10/2004
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 7 - Marketing Authorisation Holder
Updated on 09/07/2002 and displayed until 26/04/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 01/07/2002 and displayed until 09/07/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/06/2002 and displayed until 01/07/2002
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 16/08/2001 and displayed until 25/06/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/05/2002 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 09/04/2001 and displayed until 22/05/2002
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   allopurinol