Clexane Forte Syringes
Last Updated on eMC 09-Jun-2017 View document | SANOFI Contact details
Versions
- 09-Jun-2017 to Current
- 24-Sep-2015 to 09-Jun-2017
- 11-Nov-2014 to 24-Sep-2015
- 19-Feb-2014 to 11-Nov-2014
- 11-Dec-2013 to 19-Feb-2014
- 08-Jul-2013 to 11-Dec-2013
- 03-Jan-2012 to 08-Jul-2013
- 26-Jul-2011 to 03-Jan-2012
- 31-May-2011 to 26-Jul-2011
- 11-Mar-2011 to 31-May-2011
- 20-Dec-2010 to 11-Mar-2011
- 14-Oct-2010 to 20-Dec-2010
- 13-Aug-2010 to 14-Oct-2010
- 11-Nov-2009 to 13-Aug-2010
- 09-Jun-2009 to 11-Nov-2009
- 04-Jun-2003 to 09-Jun-2009
- 23-Aug-2002 to 04-Jun-2003
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 09-Jun-2017 and displayed until Current
Reasons for adding or updating:
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 28-Apr-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
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Type IAIN to implement the outcome of the Article 30 (harmonisation of the efficacy and safety sections). |
Updated on 24-Sep-2015 and displayed until 09-Jun-2017
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC: 06-Aug-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
update section 4.2 (Posology and administration) of the SPC regarding prophylaxis of venous thromboembolism for patients with a high-VTE risk who undergo abdominal or pelvic surgery for cancer and are not otherwise at high risk for major bleeding complications.
Updated on 11-Nov-2014 and displayed until 24-Sep-2015
Reasons for adding or updating:
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Date of revision of text on the SPC: 30-Oct-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 4.2: updated to add a cross reference to section 4.4 regarding the Neuraxial anaesthesia updateSection 4.4: Neuraxial anaesthesia update
Updated on 19-Feb-2014 and displayed until 11-Nov-2014
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects - how to report a side effect
Date of revision of text on the SPC: 12-Feb-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Type II C.I.4 variation to update SPC section 4.4 and 4.8 in line with the Company Core Data Sheet version 10.Updated on 11-Dec-2013 and displayed until 19-Feb-2014
Reasons for adding or updating:
- Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC: 27-Nov-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Type II C.I.4 variation to update SPC section 4.4 in line with the Company Core Data Sheet version 11.
Updated on 08-Jul-2013 and displayed until 11-Dec-2013
Reasons for adding or updating:
- Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC: 12-Jan-2012
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Update to section 7 with the Sanofi trading styleUpdated on 03-Jan-2012 and displayed until 08-Jul-2013
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-Jul-2011 and displayed until 03-Jan-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-May-2011 and displayed until 26-Jul-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
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-Mar-2011 and displayed until 31-May-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 guidelinesUpdated on 20-Dec-2010 and displayed until 11-Mar-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 indicationSection 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-Oct-2010 and displayed until 20-Dec-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 mechanismUpdated on 13-Aug-2010 and displayed until 14-Oct-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-Nov-2009 and displayed until 13-Aug-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-Jun-2009 and displayed until 11-Nov-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-Jun-2003 and displayed until 09-Jun-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-Aug-2002 and displayed until 04-Jun-2003
Reasons for adding or updating:
- Change to section 7 - Marketing Authorisation Holder
SANOFI
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
+44 (0)1483 535 432
+44 (0)1483 505 515
+44 (0)845 372 7101
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?
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