Summary of Product Characteristics
last updated on the eMC:
03/01/2012
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 03/01/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 6.1 - List of Excipients
-
Change to section 10 date of revision of the text
-
Correction of spelling/typing errors
|
| Date of revision of text on the SPC: 01-Dec-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
The layout of the wording in Section 4.2 has been amended slightly.
Section 6.1 has been amended.
|
|
Updated on 19/10/2009 and displayed until 03/01/2012
|
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 |
|