Last Updated on eMC 23-03-2018 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 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 6.2 - Incompatibilities
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:22-03-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update SPC sections 2, 4.3, 4.4, and 4.6  in line with QRD template, 4.8 in line with ADR reporting and 6.2 updated the INN name to 'sulfate'. Consequentially, the PIL and label have been updated.

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