Summary of Product Characteristics
last updated on the eMC:
14/06/2011
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 14/06/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change due to harmonisation of SPC
|
| Date of revision of text on the SPC: 01-Apr-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| New data
|
|
Updated on 06/05/2010 and displayed until 14/06/2011
|
Reasons for adding or updating:
|
-
Removal of Black Triangle
|
| Date of revision of text on the SPC: 01-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Removal of black triangle.
|
|
Updated on 23/06/2009 and displayed until 06/05/2010
|
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):
YES |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|