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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: 03/01/2012
SPC Clexane Forte Syringes

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 03/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   19-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update section 4.2 of the SPC and consequently the labelling by including dosing charts.
Updated on 26/07/2011 and displayed until 03/01/2012
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   13-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 - text added:

Enoxaparin binds to anti-thrombin III leading to inhibition of coagulation factors IIa and Xa.

Enoxaparin has been shown to increase the blood concentration of Tissue Factor Pathway Inhibitor in healthy volunteers.
Updated on 31/05/2011 and displayed until 26/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   13-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 -

The following text has been added

 

For full list of excipients, see section 6.1

Section 3 -

The following text has been added

 

Clear, colourless to pale yellow solution.


Section 6.1 - Ph. Eur removed

Section 9 - updated to:

Date of first authorisation: 22 October 1990

Date of latest renewal: 8 August 2002
Updated on 11/03/2011 and displayed until 31/05/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - side effects have been reformatted into frequency tables in line with EU guidelines
Updated on 20/12/2010 and displayed until 11/03/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   09-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 - addition of the STEMI indication
Section 4.2, 4.4, 5.2 - Inclusion of information about use of Clexane in acute MI
Section 6.2 - addition of compatibility information for IV administration.
Updated on 14/10/2010 and displayed until 20/12/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   22-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.2 and 6.5 have been updated to incorporate the addition of the safety lock mechanism
Updated on 13/08/2010 and displayed until 14/10/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   22-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of warning about increased risk of haematoma in patients with history of spinal surgery or spinal deformity.
Updated on 11/11/2009 and displayed until 13/08/2010
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change of Ownership from PL 00012/0339 to PL 04425/0185 following merger of sanofi and aventis.
Updated on 09/06/2009 and displayed until 11/11/2009
Reasons for adding or updating:
  • Joint SPC superseded by SPCs for individual presentations
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   04-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The Clexane Forte syringes have been separated from the Clexane syringes and Multidose vial SPC due to differences in licensed indications.
Change to section 9: Date of renewal of the authorisation 04/02/09
Updated on 04/06/2003 and displayed until 09/06/2009
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 23/08/2002 and displayed until 04/06/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  enoxaparin sodium