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Stiefel
Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

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: 21/12/2010
SPC Isotrexin Gel

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 21/12/2010 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:   15-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 7

GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Section 8

PL 19494/0068

Section 10

15 December 2010
Updated on 16/11/2009 and displayed until 21/12/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3     Shelf life

Reduced from 2 years to 18 months.

Section 7.       MARKETING AUTHORISATION HOLDER
Address of MAH changed.

Section 10.     DATE OF REVISION OF THE TEXT
Updated to Oct 09
Updated on 31/08/2007 and displayed until 16/11/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3
Addition of 'women intending to conceive' to groups for which Isotrexin is contraindicated.
 
Section 6.5
Addition of pack sizes
 
Section 9
Change of authorisation/renewal date
 
Section 10
Change of revision date
Updated on 06/03/2006 and displayed until 31/08/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 27/09/2005 and displayed until 06/03/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
  • SPC Retired pending re-submission
Updated on 24/08/2001 and displayed until 27/09/2005
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  erythromycin
  isotretinoin