Last Updated on eMC 16-06-2016 View medicine  | Aspen 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 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:10-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text
 

 

2                QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each vial ampoule contains 1 ml of 50 mg/ml nandrolone

6.5            Nature and contents of container

 

Deca-Durabolin 50 mg/ml solution for injection: 1 ml type I ampoules

vials. sold in packs of 1, 3 or 6 ampoules vials.

10                DATE OF REVISION OF THE TEXT

10/06/2016

Nov 2015

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:01-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Text in red = new text
Text strikethrough = deleted text



  10 DATE OF REVISION OF THE TEXT

                    July 2014

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