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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 15/09/2011
SPC Finacea 15% 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 15/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The SmPC has been updated in line with the Company core text. 
Updated on 02/06/2010 and displayed until 15/09/2011
Reasons for adding or updating:
  • Improved Electronic Presentation
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 06/05/2009 and displayed until 02/06/2010
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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 2 - Qualitative and quantitative composition
Content of azelaic acid expressed as mg instead of g
Details of individual excipient contents removed.
 
Change to section 4.2 - Posology and method of administration
Statement regarding use in children under 12 added (moved from 4.4)
 
Change to section 4.3 - Contraindications 
specific contraindication regarding propylene glycol hypersensitivity removed (general statement regarding hypersensitivity to any excipient remains).
 
Change to section 4.4 - Special warnings and precautions for Use 
Additional information on hypersensitivity reactions to benzoic acid and propylene glycol included.
Statement regarding use in children under 12 deleted (moved to 4.2)
 
Change to section 4.5 - Interaction with other Medicinal Products 
Minor rewording
 
 Change to section 4.7 - Effects on Ability to Drive and Use Machines 
Amended to state that there is no influence on ability to drive and use machines
 
Change to section 4.8 - Undesirable effects
Frequency of undesirable effects now reported separately for acne and rosacea indications and updated in line with available data.  System organ class added and summary tables reorganised.
 
 Change to section 6. 4 - Special Precautions for Storage
Minor rewording.
 
Change to section 9 - Date of First Authorisation/Renewal of Authorisation
Date of renewal added
 
Change to section 10 - Date of Revision of Text
Updated date of revision
Updated on 13/09/2006 and displayed until 06/05/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/09/2006 and displayed until 13/09/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  azelaic acid