Summary of Product Characteristics
last updated on the eMC:
03/12/2009
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 03/12/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 25-Nov-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 9 has been updated to reflect current licence date.
|
|
Updated on 27/11/2009 and displayed until 03/12/2009
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 25-Nov-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
In section 4.8 (Undesirable effects) have been updated to read:
Immune system disorders: Hypersensitivity reactions
General disorders: Application site irritation, swelling or inflammation
|
|
Updated on 28/07/2009 and displayed until 27/11/2009
|
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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
