| Modification | Date |
| Change to section 10 date of revision of the text | 28/10/2009 18:56:01 |
| Change to section 9 - Date of first Authorisation/renewal of the Authorisation | 28/10/2009 18:56:01 |
| Change to section 6. 3 - Shelf Life | 28/10/2009 18:56:01 |
| Change to section 7 - Marketing Authorisation Holder | 28/10/2009 18:56:01 |
| New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC | 12/07/2006 12:13:17 |
|