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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: 29/03/2012
SPC PanOxyl 5 Cream

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 29/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Mar-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


2  Update to include excipient warnings

4  BenOxyl has been changed to PanOxyl throughout

4.2  More details provided as to when to apply and how long to use. Age for children has been specified.

4.4  Additional warnings on usage and potential effects – reddening, irritation and sensitivity to light. Excipient warning added.

4.5  Interactions with tretinoin, isotretinoin and tazarotene added

4.6  More information provided in this section on what data is available regarding fertility, pregnancy and lactation

4.7  Update to QRD template

4.8  Adverse event information has been updated. Sections now included on Immune System, Skin and Sub-cutaneous Tissue Disorders, General Disorders and Administration site conditions.

4.9  Information now included

5.1  Updated with more information

5.2  Updated with more information

5.3  Updated with more information

6.5  QRD Template update

10  Updated with new date of revision of text
Updated on 18/11/2011 and displayed until 29/03/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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-Nov-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - alignment of SPC to Excipient Guidelines ref propylene glycol
Section 4.4 - propylene glycol - addition of information re skin irritation
Section 10 - date of revision
Updated on 23/12/2010 and displayed until 18/11/2011
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:   20-Dec-2010
Legal Category:   P
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 19494/0077
Section 10 - 20 December 2010
Updated on 25/08/2009 and displayed until 23/12/2010
Reasons for adding or updating:
  • 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:   17-Aug-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7: Update to the address of the MAH

Section 10: Date updated 
Updated on 22/09/2006 and displayed until 25/08/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
Date of revision of text on the SPC:   09/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 Corrected to 'known hypersensitivity to any of the ingredients'
Updated on 27/09/2005 and displayed until 22/09/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 24/08/2001 and displayed until 27/09/2005
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
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