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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: 04/05/2012
SPC Leustat Injection.

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 04/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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:   01-May-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Summary of changes:

·         Update to the SmPC section 4.8 (Undesirable effects) to amalgamate clinical trial and post-marketing adverse drugs reactions in one table.

·         Correction of a typographical error in section 5.3 (preclinical safety).

Updated on 20/01/2012 and displayed until 04/05/2012
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:   16-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life reduced to 2 years
Updated on 20/08/2010 and displayed until 20/01/2012
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   17-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Extensive update to section 4 of the SmPC following implementation of Core Safety Profile e.g., warnings added to section 4.4 re serious infections, Coomb's positive patients, elderly patients, paediatric use. Addition of new side effects to section 4.8
Updated on 22/07/2008 and displayed until 20/08/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to MA holder contact details
Date of revision of text on the SPC:   17-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


REASON(S) FOR SUBMISSION

Change

eMC - Summary of Change Details Per Section

(please DO NOT use the track changes)

 

 

Change to section 7 – Marketing Authorisation Holder

Change of Address

 

Change to MA holder contact details

Change of Address
Updated on 09/11/2006 and displayed until 22/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to separate SPCs covering individual presentations
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

4.8

Undesirable effects

X  (and deletion of Appendix 1 to the SPC)

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

3 February 1995/ 7 October 2004

10.

DATE OF REVISION OF THE TEXT

 

November 2006

 

 

Change to separate SPCs covering individual presentations                                                                                                                                                                                                      

X, update to Section 4.8
Updated on 20/09/2006 and displayed until 09/11/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/03/2004 and displayed until 20/09/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/08/2001 and displayed until 23/03/2004
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

 
  cladribine