Summary of Product Characteristics
last updated on the eMC:
02/04/2012
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 02/04/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
|
| Date of revision of text on the SPC: 26-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Storage conditions have been changed from 'Store below 30°C', to 'Do not store above 25°C'.
|
|
Updated on 09/12/2010 and displayed until 02/04/2012
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 5.3 - Preclinical Safety Data
|
| Date of revision of text on the SPC: 20-Oct-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 4.8 (undesirable effects) of the SPC, swelling face has been added. Some additional information has also been added to section 5.3 (Pre-Clinical Safety Data) of the SPC.
|
|
Updated on 11/01/2010 and displayed until 09/12/2010
|
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 |
|
