Last Updated on eMC 25-07-2012 View medicine  | Ferring Pharmaceuticals 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 MA holder contact details

Date of revision of text on the SPC:27-06-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

New MAH address: Drayton Hall, Church Road, West Drayton, UB7 7PS

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:16-05-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.8 (undesirable effects), disorders including aggression in children......has been added.

Reasons for adding or updating:

  • Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC:01-07-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 6.3: Shelf life extended from 2 years to 3 years.

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 (date of (partial) revision of the text

Date of revision of text on the SPC:05-11-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 5.1 has been updated to include the EC50 value

Section 5.2 has been updated to include information on plasma concentration

Section 10 has been update to reflect the variation approval date.

Reasons for adding or updating:

  • Change to section 9 - Date of Renewal of Authorisation

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Reasons for adding or updating:

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

Reasons for adding or updating:

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

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied