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

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: 30/04/2012
SPC Olbetam Capsules 250

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 30/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 Marketing Authorisation Holder: Changed to Pfizer Limited
Section 8 Marketing Authorisation Number: Updated to reflect new PL number 00057/1022
Section 10 Date of revision of the: Updated to 04/2012
Updated on 24/05/2011 and displayed until 30/04/2012
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
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
Section 4.3 – minor change
Section 4.4 – additional wording
Section 4.5 – new interaction information
Section 4.8 – reformatted to include frequency and MeDRA system organ class
Updated on 22/03/2010 and displayed until 24/05/2011
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   13-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.7, Effects on ability to drive and use machines updated to read: “The effect of acipimox on ability to drive or use machinery has not been studied, but based on its pharmacodynamic properties and overall safety profile it is unlikely to have an effect”.

Section 4.8, Undesirable effects updated according to the MedDRA terminology and reorganized events by system organ Class (SOC).

Updated on 12/06/2007 and displayed until 22/03/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 7  Change to Marketing Authorisation Holder address
Updated on 20/03/2007 and displayed until 12/06/2007
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:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 4.4  Name of active ingredient changed from Cholestyramine to Colestyramine to comply with the Directives authorised the use of recommended International Nonproprietary Names in the labelling of medicines throughout the European Community
 
Section 10  Update to date of revision of the text
Updated on 19/05/2003 and displayed until 20/03/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/02/2003 and displayed until 19/05/2003
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
Updated on 11/07/2001 and displayed until 21/02/2003
Reasons for adding or updating:
  • Transferred from eMC version 1

Active Ingredients/Generics

 
  acipimox