Last Updated on eMC 08-05-2018 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 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:03-05-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update SmPC sections 2, 4.3, 4.6, 4.8, 4.9, 6.2, 6.3 and 9 in line with QRD template, ADR reporting and INN name 'sulfate' in line with current wording. Also, leaflet has 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:29-12-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

ADR reporting details

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:04-03-2011

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

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:18-09-2009

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. 

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:20-02-2009

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

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:01-10-2007

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

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:01-05-2006

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

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation