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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: 10/05/2012
SPC Detrusitol 1mg & 2mg 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 10/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC Sections 7 - updated with Pfizer; Section 8 - updated with new PL number



Updated on 23/02/2009 and displayed until 10/05/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Type II variation to update section 4.8
Updated on 04/12/2008 and displayed until 23/02/2009
Reasons for adding or updating:
  • 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-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


- Minor change to section 4.5 to include an additional iso-enzyme.
- Update to section 4.8 to include additional side effects within the table and discuss impact on dementia.
Updated on 29/11/2007 and displayed until 04/12/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.8 – Changes to side effects section including addition of new side effects  

Updated on 15/06/2007 and displayed until 29/11/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 14/06/2007 and displayed until 15/06/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 11/06/2007 and displayed until 14/06/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
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
 

Sections changed: 4.2, 4.8, 5.1, 5.2

The SPC was updated in line with the text agreed during the EU Worksharing procedure for paediatric data for this product. 

Updated on 03/05/2007 and displayed until 11/06/2007
Reasons for adding or updating:
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.6 - Adminstrative changes
Updated on 08/11/2005 and displayed until 03/05/2007
Reasons for adding or updating:
  • Change to section 1 - trade name
Updated on 19/01/2005 and displayed until 08/11/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 7 - Marketing Authorisation Holder
Updated on 02/12/2003 and displayed until 19/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2003 and displayed until 02/12/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 25/09/2003 and displayed until 30/09/2003
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  tolterodine tartrate