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Abbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK
Telephone: +44 (0)1628 773 355
Fax: +44 (0)1628 644 185
WWW: http://www.abbottuk.com
Medical Information e-mail: ukmedinfo@abbott.com
Out of Hours Telephone: +44 (0)1628 774 920

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: 08/05/2012
SPC Norvir 100mg 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 08/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2 has been updated to reflect the annual review of protease inhibitors.
Updated on 05/04/2012 and displayed until 08/05/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

A warning regarding the use of tenofovir disoproxil fumarate has been added to Section 4.4.

The table in Section 4.8 has been amended throughout to update the frequencies as well as reorder some of the adverse reactions under a more accurate system organ class.
Updated on 11/01/2012 and displayed until 05/04/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8 has been updated to include toxic epidermal necrolysis (TEN) as a rare adverse event.
Updated on 08/12/2011 and displayed until 11/01/2012
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 4.5, interaction statements have been for fentanyl, dasatinib, nilotinib, tadalafil, bosentan and colchicine.
Updated on 29/04/2010 and displayed until 08/12/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   16-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Addition of a new pack size of 90 tablets (3 bottle of 30 tablets)
Updated on 20/04/2010 and displayed until 29/04/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided

Active Ingredients/Generics

 
   ritonavir