Last Updated on eMC 03-04-2018 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities

Date of revision of text on the SPC:27-03-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update SPC sections 2, 4.6, 4.8 and 6.2 in line with QRD template, ADR reporting information and INN name to 'sulfate'. Also, updated label and leaflet

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:07-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

How to report a side effect 

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:01-08-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - CP Pharmaceuticals Limited amended to Wockhardt UK Limited

Section 8 - PL 04543/0228 amended to PL 29831/0112

Section 9 - Date of first authorisation amended

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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:01-09-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1 – name of product amended to include pharmaceutical form

 

Section 4.4 – platelet monitoring amended from seven to five days

 

Section 10 – date of revision amended

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation