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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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: 04/01/2011
SPC Ditropan Tablets 2.5mg, Ditropan Tablets 5mg

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 04/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   17-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Information in sections 4.1 and 4.4 on use in paediatric population has been revised
Updated on 17/11/2009 and displayed until 04/01/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5 - addition of clozapine
Updated on 25/08/2009 and displayed until 17/11/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Company name change or merger
Date of revision of text on the SPC:   29-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of ownership following merger.
Updated on 18/09/2007 and displayed until 25/08/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Market Authorisation Holder): change to sanofi-aventis.
Updated on 20/09/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 19/09/2006 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 04/04/2005 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 04/08/2004 and displayed until 04/04/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • 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 4.9 - Overdose
Updated on 26/09/2002 and displayed until 04/08/2004
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/08/2001 and displayed until 21/08/2001
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  oxybutynin hydrochloride