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Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
Telephone: +44 (0)1442 341 234
Fax: +44 (0)1442 341 200

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: 08/06/2011
SPC OPATANOL 1mg/ml eye drops solution

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 08/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   24-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Harmonisation to be in line with last approval from the EMEA. Last approval of changes not directly affecting the SmPC.
Updated on 20/01/2009 and displayed until 08/06/2011
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   21-Aug-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - Whole section amended

Section 3 - Whole section amended

Section 4.2 - 'Use in children and adolescents' paragraph removed, replaced with 'Paediatric patients'

Section 4.3 - Whole section amended

Section 4.5 - 'No clinical interaction studies were performed with Opatanol' has been changed to 'No interaction studies have been performed'

Section 4.8 - Whole section amended

Section 5.3 - The word 'preclinical' has been changed to 'Non-clinical'

Section 6.2 - 'None known' has been changed to 'Not applicable'

Section 6.4 - Whole section amended

Section 6.5 - Whole section amended

Section 9 - Date of last renewal added

Section 10 - Date added
Updated on 06/03/2007 and displayed until 20/01/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   05/2002
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Removal of black triangle
Updated on 14/03/2003 and displayed until 06/03/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  olopatadine (as hydrochloride)