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Almirall Limited

4 The Square, Stockley Park, Uxbridge, UB11 1ET, UK
Telephone: +44 (0) 207 160 2500
Fax: +44 (0) 208 756 3888
WWW: http://www.almirall.com
Medical Information Direct Line: 0800 0087399
Medical Information e-mail: almirall@professionalinformation.co.uk
Customer Care direct line: +44 (0) 207 160 2500
Medical Information Fax: +44 (0) 1748 828 801

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: 17/03/2011
SPC Lodine SR

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 17/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   26-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 updated to reflect change in MAH details from "Laboratorios Almirall SA" to "Almirall SA"
Updated on 22/07/2009 and displayed until 17/03/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   09-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 of the SPC updated following a Type II variation to include updated minimum particulars for NSAIDs.
Updated on 02/01/2009 and displayed until 22/07/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   01-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of MAH from Shire to Almirall
Updated on 12/03/2007 and displayed until 02/01/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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:   03/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.2 - The addition of a sentance on 'how to minimize undersirable effects'
Change to section 4.4 - Addition of cardiovascular and cerebrovascular effects
Change to section 4.8 - Addition of oedema, hypertension and cardiac falure
Change to section 10 -  05 March 2007
Updated on 31/10/2002 and displayed until 12/03/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/07/2001 and displayed until 31/10/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/10/2000 and displayed until 13/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  etodolac