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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: 01/12/2011
SPC Opticrom Allergy 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 01/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   20-Apr-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 - ATC code added
Updated on 28/04/2011 and displayed until 01/12/2011
Reasons for adding or updating:
  • 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:   20-Apr-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
New text shown in blue below:-

Section 4.4 Special warnings and precautions for use

Discard any remaining contents four weeks after opening the bottle.

 

As with other ophthalmic solutions containing Benzalkonium chloride, soft contact lenses should not be worn during treatment period.

 

Sodium cromoglicate can be used prophylactically.  Patients should seek advice before they discontinue use of the product.
Updated on 24/07/2009 and displayed until 28/04/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Jun-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1: Now called Opticrom Allergy 2.0% w/v Eye Drops Solution
Section 2: Added statement: For full list of excipients, see section 6.1
Section 3: Following information replaces current text: Eye Drops, Solution (Eye Drops). A clear colourless, or pale yellow liquid
Updated on 24/11/2008 and displayed until 24/07/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Sep-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to date of revision to 2 September 2008
Updated on 18/09/2007 and displayed until 24/11/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   12/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change in MA Holder's address
Updated on 31/12/2004 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change from the BAN of the active substance to the rINN
Updated on 14/03/2003 and displayed until 31/12/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  sodium cromoglicate