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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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: 28/06/2011
SPC Stugeron 15 mg

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 28/06/2011 and displayed until Current
Reasons for adding or updating:
  • 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:   22-Jun-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - Updated according to current requirements and for additional ADRs
Change to section 10 - 22 June 2011
Updated on 20/07/2010 and displayed until 28/06/2011
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Jul-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 5.3 - addition of new data.
Change to section 10 - 15 July 2010.
Updated on 03/02/2010 and displayed until 20/07/2010
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jan-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 5.2 - Pharmacokinetic properties

re-written to provide more detail

Change to section 10 – Date of revision of the text

Changed to 28 Jan 10
Updated on 14/01/2010 and displayed until 03/02/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Dec-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 6.3 – Shelf Life

Reduction in shelf life from 5 years to 3 years

Change to section 10 – Date of revision of the text

Changed to 24 Dec 09
Updated on 05/01/2010 and displayed until 14/01/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Dec-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 5.1 - Addition of ATC code
Change to section 10 - Changed to 23 Dec 09
Updated on 01/05/2009 and displayed until 05/01/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Apr-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 7 – Marketing Authorisation Holder

Address change of MAH

Change to section 10 – Date of revision of the text

28 April 2009
Updated on 28/02/2006 and displayed until 01/05/2009
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/02/2006 and displayed until 28/02/2006
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 10 (date of (partial) revision of the text
Updated on 20/09/2002 and displayed until 16/02/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 27/08/2002 and displayed until 20/09/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 22/08/2002 and displayed until 27/08/2002
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 04/09/2001 and displayed until 22/08/2002
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
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