Summary of Product Characteristics
last updated on the eMC:
24/09/2008
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 24/09/2008 and displayed until Current
|
Reasons for adding or updating:
|
-
Addition of separate SPCs covering individual presentations
-
Change to section 4.3 - Contraindications
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 7 - Marketing Authorisation Holder
-
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-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Completely updated version of SmPC reflecting changes to sections 4.3, 4.5 and 4.8 as well as change in MAH and update of format to QRD template.
|
|
Updated on 27/09/2005 and displayed until 24/09/2008
|
Reasons for adding or updating:
|
-
Addition of separate SPCs covering individual presentations
|
|