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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: 17/01/2012
SPC Nevanac 1mg/ml eye drops, suspension

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 17/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   22-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Changes following the approval of a variation to add an indication:

4.1          Therapeutic indications

Nevanac is indicated for:

- Prevention and treatment of postoperative pain and inflammation associated with cataract surgery

- Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.(see section 5.1)
Updated on 11/05/2011 and displayed until 17/01/2012
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
In Section 3, Pharmaceutical form, the colour of the suspension 'Light yellow to dark yellow' is changed to 'Light yellow to light orange'.

In Section 10, Date of revision of the text, the date of revision is updated.
Updated on 20/05/2009 and displayed until 11/05/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  nepafenac