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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 28/02/2012
SPC Brolene Eye Drops

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 28/02/2012 and displayed until Current
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:   24-Feb-2012
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Type A.1 bulk variation to register an additional trading style of the Marketing Authorisation Holder.
Updated on 20/04/2010 and displayed until 28/02/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   12-Apr-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - addition of eye pain and irritation
Updated on 24/07/2009 and displayed until 20/04/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   07-Jul-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3: shelf life changed from 36 months to 24 months
Updated on 18/11/2008 and displayed until 24/07/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Nov-2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of non-marketed presentation details from section 6.5, as incorect when updated.
text removed: or 10 ml plastic dropper bottle and tamper-proof cap together with an autodrop device as a separate item.
Updated on 11/09/2007 and displayed until 18/11/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to sanofi-aventis.
Updated on 08/08/2005 and displayed until 11/09/2007
Reasons for adding or updating:
  • Change from BAN to rINN
Updated on 27/09/2004 and displayed until 08/08/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 05/12/2002 and displayed until 27/09/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  propamidine isetionate