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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

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: 11/05/2012
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 11/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


7.         Marketing Authorisation Holder changed from Aspen Europe GmbH,  32-36 Industriestrasse, D-23840 Bad Oldesloe, Germany to
Aspen Pharma Trading Limited,12/13 Exchange Place, I.F.S.C, Dublin 1, Ireland

12/13 Exchange Place, I.F.S.C, Dublin 1, Ireland

 

 

8.         Marketing Authorisation Number for Zyloric 100mg Tablets changed from PL 35468/0006 – to PL 39699/0001 and for Zyloric-300mg Tablets from  PL 35468/0007 to PL 39699/0002

10.       Date of (Partial) Revision of the Text changed from 07 December 2009 to February 2012

 

 
Updated on 15/04/2011 and displayed until 11/05/2012
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