Last Updated on eMC 12-03-2014 View medicine  | Meda Pharmaceuticals 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:29-11-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Update to add MHRA's yellow card ADR statement

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC:08-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:08-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.3 Shelf Life$018 months$0$024 Months$0$0$0$0$07. MARKETING AUTHORISATION HOLDER$0$0Meda Pharmaceuticals Ltd$0$0249 West George Street$0$0Glasgow$0$0G24RB$0$0$0$0$0Trading as:$0$0$0$0$0Meda Pharmaceuticals Ltd$0$0Skyway House$0$0Parsonage Road$0$0Takeley$0$0Bishop's Stortford$0$0CM22 6PU$0$0$0$0$0$0$0$010. DATE OF REVISION OF THE TEXT$0$011th August 2010$0$0$0$0$008 May 2013 $0$0

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients

Date of revision of text on the SPC:11-08-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Wording removed from sections 3 and 6.1 of the SPC

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)

Date of revision of text on the SPC:03-11-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to sections 7 and 8 following Change of Ownership

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