Last Updated on eMC 04-03-2016 View medicine  | Wockhardt UK Ltd Contact details

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.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:17-11-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

ADR reporting system details

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-08-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Product has been debranded.

Section 1 - generic name has been added - Heparin Sodium 100 I.U./ml flushing solution for maintenance of patency of intravenous devices

Reasons for adding or updating:

  • Change of Marketing Authorisation Holder

Date of revision of text on the SPC:01-09-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

MA Holder amended from 'CP Pharmaceuticals Ltd' to 'Wockhardt UK Ltd'

PL 04543/0322 amended to PL 29831/0111

Reasons for adding or updating:

  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:01-04-2004

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 10 - change of revision of text

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation