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Stiefel Ireland
GlaxoSmithKline (Ireland) Ltd, Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 20/09/2011
SPC Isotrex Gel 0.05%w/w

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 20/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MA number
Date of revision of text on the SPC:   03-Dec-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 8:

Incorret PA number in Section 8 - should have read PA 1077/122/001
Updated on 18/08/2011 and displayed until 20/09/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   03-Dec-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).
Updated on 12/04/2010 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   16-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


In Section 1 the IMB has updated the name to Isotrex 0.05% w/w Gel

In Section 4.4 the excipient warning has been added:

"Butylated hydroxytoluene may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes."

In Section 10 the date of revision of text has been updated to March 2010.
Updated on 22/09/2009 and displayed until 12/04/2010
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details
  • Change to section 6.1 - List of excipients
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   04-Sep-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2: Excipient butylated hydroxytoluene has been added & reference to Section 6.1 included

Section 6.1: (E321) has been added after butylated hydroxytoluene

Section 6.2 "None" changed to "Not applicable"

Section 6.3: Instruction included to discard any unused portion (within 2 months after opening)

Section 6.4: Instruction added to "Replace cap securely after use"

Section 6.6: "None" changed to "No special requirements"

Section 7: Updated with new contact details of MAH:
Stiefel Labs (UK) Ltd
Eurasia Headquarters
Concorde Road
Maidenhead
SL6 4BY
United Kingdom

Section 9: Updated with date of last renewal 18th August 2007

Section 10: Updated with date of revision of text September 2009
Updated on 30/08/2006 and displayed until 22/09/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/06/2003 and displayed until 30/08/2006
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Isotretinoin