Summary of Product Characteristics
last updated on the eMC:
04/10/2011
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 04/10/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 27-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In Section 4.8 additional information has been included in the table of undesirable effects and frequencies.
|
|
Updated on 16/11/2010 and displayed until 04/10/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 05-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 6.3
The shelf life as packaged for sale has been increased from 30 months to 3 years.
No other changes have been made to the rest of the data in this section.
|
|
Updated on 27/03/2009 and displayed until 16/11/2010
|
Reasons for adding or updating:
|
|
|
| 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 |
|
