Last Updated on eMC 21-03-2017 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 section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:20-12-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

To include:

Clotting disorders

Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:29-05-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

section 4.4: To include special warning for - ischaemic heart disease.
                                                                    - a rise in blood pressure for Men
                                                                    - regular monitor of haemoglobin, and haematocrit, liver function tests and lipid profile. 
                                                                    - limited experience in age group 65 and above

section 4.8: To include ADR details

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:

  • New SPC for new product

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

Legal Category:POM

Black Triangle (CHM): NO