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Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
Telephone: +44 (0)1276 692 255
Fax: +44 (0)1276 698 449
Medical Information Direct Line: +44 (0)1276 698 370
Medical Information e-mail: medinfo.uk@novartis.com
Customer Care direct line: +44 (0)845 741 9442

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: 06/02/2012
SPC Diovan 40mg film-coated Tablets

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 06/02/2012 and displayed until Current
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:   30-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Update to section 4.4 to add the the following information:-

History of angioedema

Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should be immediately discontinued in patients who develop angioedema, and Diovan should not be re-administered.
Updated on 03/05/2011 and displayed until 06/02/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8

To include hyponatraemia in metabolism and nutrition disorders in the tables for Hypertension and Post-myocardial infarction and/or heart failure.

Section 6.1

Include type A after crospovidone.

Section 9

Renewal granted on 03 November 2010
Updated on 10/01/2011 and displayed until 03/05/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   16-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 30/12/2010 and displayed until 10/01/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Valsartan 40mg film-coated tablets has been added as a product name to section 1.
Updated on 22/06/2010 and displayed until 30/12/2010
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
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

 
  valsartan