Summary of Product Characteristics
last updated on the eMC:
27/09/2010
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 27/09/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 01-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.9 Overdose regarding the risk of unintended oral ingestion and management of overdose. |
|
Updated on 23/12/2004 and displayed until 27/09/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|