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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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: 20/02/2012
SPC Retin-A Gel 0.025%

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 20/02/2012 and displayed until Current
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:   14-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.5:  Addition of benzoyl peroxide, soaps, shampoos, cosmetics, and products with high concentrations of alcohol, astringents, spices or lime.

Change to section 10:  14 February 2012
Updated on 31/10/2011 and displayed until 20/02/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 5.1 – Pharmacodynamic Properties : Addition of pharmacotherapeutic group and ATC code

Change to section 5.2 - Pharmacokinetic Properties : Complete change including addition of paediatric data

Change to section 10 - Date of revision of the text : 26 October 2011
Updated on 31/08/2011 and displayed until 31/10/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.2 Addition of statement regarding use in children
Updated on 09/06/2011 and displayed until 31/08/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 2 - addition of excipients
Change to section 3 - addition of description of gel
Change to section 6.2 - change to state 'not applicable'
Change to section 10 - 05 June 2011
Updated on 21/10/2010 and displayed until 09/06/2011
Reasons for adding or updating:
  • 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:   19-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.5 – minor change to the wording: “Aluminium tube with polypropylene cap”

Section 10 – 19 0ctober 2010
Updated on 29/09/2010 and displayed until 21/10/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life extension to 3 years
Section 10 - 28 September 2010
Updated on 20/07/2009 and displayed until 29/09/2010
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:   29-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder*

Address change

Change to section 10 – Date of revision of the text

29 June 2009
Updated on 30/09/2004 and displayed until 20/07/2009
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 29/09/2004 and displayed until 30/09/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
Updated on 28/09/2004 and displayed until 29/09/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/09/2004 and displayed until 28/09/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  tretinoin