Summary of Product Characteristics
last updated on the eMC:
28/02/2012
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 28/02/2012 and displayed until Current
|
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: 24-Feb-2012 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Type A.1 bulk variation to register an additional trading style of the Marketing Authorisation Holder.
|
|
Updated on 01/12/2011 and displayed until 28/02/2012
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 30-Oct-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| section 10 updated to 30 October 2009
|
|
Updated on 06/11/2009 and displayed until 01/12/2011
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 25-Sep-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 6.1
Plastibase 30W has changed to Plastibase 50W
|
|
Updated on 04/12/2008 and displayed until 06/11/2009
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 01-Jun-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change to use sanofi-aventis trading style
|
|
Updated on 28/06/2007 and displayed until 04/12/2008
|
Reasons for adding or updating:
|
|
|
|