Summary of Product Characteristics
last updated on the eMC:
25/04/2012
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 25/04/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 21-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
In section 6.3, the shelf life for vials 50ml to 200ml (only) has been reduced from 60 to 36 months
|
|
Updated on 05/03/2009 and displayed until 25/04/2012
|
Reasons for adding or updating:
|
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
|
| Date of revision of text on the SPC: 21-Jun-2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Correction of a typographical error
|
|
Updated on 04/06/2008 and displayed until 05/03/2009
|
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 |
|