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Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone: +44 (0)1978 661 261
Fax: +44 (0)1978 660 130

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: 22/03/2011
SPC Heparin sodium 25,000 I.U./ml solution for injection or concentrate for solution for infusion (with preservative)

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 22/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   04-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 amended to include information regarding maintenance during unstable angina and acute peripheral arterial occlusion
Updated on 19/03/2010 and displayed until 22/03/2011
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
Date of revision of text on the SPC:   18-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of information relating to "heparin resistance" in sections 4.2 & 4.4. 
Updated on 22/06/2009 and displayed until 19/03/2010
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:   20-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelf life extended from 18 to 36 months

Section 10 -  Date of revision amended
Updated on 18/03/2009 and displayed until 22/06/2009
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
Date of revision of text on the SPC:   01-Oct-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7- MA holder amended to Wockhardt UK Ltd

Section 8 - MA number amended from PL 04543/0220 to PL 29831/0108

Section 9 - date of first authorisation amended
Updated on 25/09/2006 and displayed until 18/03/2009
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 1: product debranded, name amended

 

Section 4.3 & 4.4: text regarding the preservatives benzyl alcohol and methyl parahydroxybenzoate added.

 

Section 6.4: information added regarding stability

 

Section 10: date of revision amended
Updated on 14/05/2003 and displayed until 25/09/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 13/08/2002 and displayed until 14/05/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation

Active Ingredients/Generics

 
  heparin sodium