Summary of Product Characteristics
last updated on the eMC:
04/07/2008
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 04/07/2008 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 16-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 4.8 (undesirable effects), disorders including aggression in children......has been added.
|
|
Updated on 17/09/2007 and displayed until 04/07/2008
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| section 6.3: Shelf life extended from 2 to 3 years.
|
|
Updated on 22/05/2006 and displayed until 17/09/2007
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 11/05/06 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 5.1 has been updated to include the EC50 value
Section 5.2 has been updated to include information on plasma concentration
Section 10 has been update to reflect the variation approval date.
|
|
Updated on 04/07/2003 and displayed until 22/05/2006
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of Renewal of Authorisation
|
|
Updated on 10/06/2003 and displayed until 04/07/2003
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 05/08/2002 and displayed until 10/06/2003
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
Updated on 09/08/2001 and displayed until 05/08/2002
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
Updated on 15/05/2001 and displayed until 09/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 17/01/2001 and displayed until 15/05/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 17/01/2001
|
Reasons for adding or updating:
|
|
|
|
