Summary of Product Characteristics
last updated on the eMC:
07/09/2009
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.
Updated on 07/09/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 01-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to Section 7. Marketing Authorisation details
|
|
Updated on 30/03/2009 and displayed until 07/09/2009
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 01-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 9. Date of First Authorisation
Section 10. Date of Revision of text
|
|
Updated on 03/07/2008 and displayed until 30/03/2009
|
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: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
