Last Updated on eMC 06-07-2017 View medicine  | Swedish Orphan Biovitrum 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 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:23-06-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



4.         Clinical particulars

4.2         Posology and method of administration

 

Inserted (additional text highlighted in bold): 100 IU/kg once every 10 days, adjust interval based on individual response. Some patients who are well-controlled on a once every 10 days regimen might be treated on an interval of 14 days or longer.

 

 

4.8          Undesirable effects

 

Inserted: Post Marketing Experience: In post-marketing experience, FIX inhibitor development and hypersensitivity have been observed.

               

 

10.       DATE OF REVISION OF THE TEXT

 

Deleted: 30th Sept 2016

Inserted: 23rd June 2017

Reasons for adding or updating:

  • 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:30-09-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Summary of Product Characteristics changes:

7. MARKETING AUTHORISATION HOLDER
Biogen removed and Swedish Orphan Biovitrum added.
 

10. DATE OF REVISION OF THE TEXT

 12th May 2016 removed and revision date of 30th September 2016 added.

Reasons for adding or updating:

  • New SPC for new product

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

Legal Category:POM

Black Triangle (CHM): YES