Summary of Product Characteristics
last updated on the eMC:
01/12/2008
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 01/12/2008 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 18-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.4 - Addition of class warning for anti-epileptics regarding suicidal ideation and behaviour.
|
|
Updated on 02/11/2005 and displayed until 01/12/2008
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 6.1 - List of Excipients
-
Change to section 1 - trade name
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 3 - pharmaceutical form
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 6 - Instruction for Use/Handling
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 30/09/2003 and displayed until 02/11/2005
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|