Last Updated on eMC 14-10-2016 View medicine  | Ethypharm 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 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:01-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



The SmPC has a change in wording to section 4.4 of the SmPC (additional warning concerning misuse and abuse) following the outcome of a PSUR work sharing procedure (NL/H/PSUR/0021/005).

 

The following recommended text was inserted at the end of section 4.4  prior to the 'Additional information' sub-section:

 

“Misuse and abuse

Cases of misuse and abuse have been reported. Caution may be needed when prescribing quetiapine to patients with a history of alcohol or drug abuse.”

 

There was no change to the PIL or labels with this variation.

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text
  • Company name change or merger

Date of revision of text on the SPC:01-07-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - Change of company name from DB Ashbourne Ltd to Ethypharm UK Ltd.  Change of registered address.
Section 10 - Date of revision of text changed to July 2016

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:31-03-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 - Marketing Authorisation Holder changed from Dallas Burston Ashbourne to DB Ashbourne Ltd
Section 8 - Marketing Authorisation Numbers changed from:-
 

PL20311/0026 to PL 42623/0059

PL20311/0027  to PL 42623/0060

PL20311/0028  to PL 42623/0061

PL20311/0029  to PL 42623/0062


Section 10 - Date of Revision of the text change from September 2015 to March 2016

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO