Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Summary of Product Characteristics last updated on the eMC: 24/05/2011
SPC Lopid 300mg hard capsules & 600mg 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 24/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

SmPC: change to section 6.5 Nature and contents of container – addition of new pack sizes
Updated on 06/04/2011 and displayed until 24/05/2011
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 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Extensive changes to the following sections: 1, 2, 3, 4.1, 4.8, 5.1, 6.1 and 6.4.
Updated on 20/04/2010 and displayed until 06/04/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 3: Amendment to clarify the pharmaceutical form and the description of the capsule and tablet

Section 6.1: Amendment to the list of excipients

Section 6.4: Amendment to the storage instruction

Updated on 08/08/2007 and displayed until 20/04/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.1 – List of excipients

Section 10 – Change to the date of revision of text

Updated on 06/06/2006 and displayed until 08/08/2007
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   01/12/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to section 9 - Date of Renewal of Authorisation and Change to section 10 (date of (partial) revision of the text
Updated on 28/09/2005 and displayed until 06/06/2006
Reasons for adding or updating:
  • Addition of joint SPC covering all presentations

Active Ingredients/Generics

 
   gemfibrozil