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Cephalon (UK) Limited
1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT
Telephone: +44 (0) 1707 385800
Fax: +44 (0) 1707 385801
WWW: http://www.cephalon.co.uk
Medical Information Direct Line: 0800 783 4869
Medical Information e-mail: ukmedinfo@cephalon.com
Medical Information Fax: +44 (0) 1707 385802

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: 05/11/2009
SPC TARGRETIN CAPSULES

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 05/11/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   06-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in address of Marketing Authorisation Holder
Updated on 19/06/2007 and displayed until 05/11/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 - Marketing Authorisation Holder

 

changed to:

 

Eisai Ltd.

3 Shortlands

London

W6 8EE

United Kingdom
Updated on 12/07/2006 and displayed until 19/06/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 (shelf-life) Extension of shelf life from 2 to 3 years
Updated on 15/06/2006 and displayed until 12/07/2006
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   04/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Black Triangle (¥) has been removed as it no longer applies
Updated on 31/05/2006 and displayed until 15/06/2006
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:   01/04/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 Section 4.8 (undesirable Effcets) was reorganised to clarify those adverse events expected when Targretin is used in the approved indication as opposed to adverse events observed in non-CTCL trials or non-approved CTCL dosage
Updated on 27/09/2005 and displayed until 31/05/2006
Reasons for adding or updating:
  • Addition of Black Triangle
  • Change to section 10 (date of (partial) revision of the text
Updated on 01/06/2004 and displayed until 27/09/2005
Reasons for adding or updating:
  • Company name change or merger
Updated on 28/05/2004 and displayed until 01/06/2004
Reasons for adding or updating:
  • Company name change or merger
  • Pending awaiting re-submission
Updated on 11/01/2002 and displayed until 28/05/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  bexarotene