Summary of Product Characteristics
last updated on the eMC:
10/02/2010
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 10/02/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 02-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Changes to sections 7, 8 and 10 following change of ownership approval.
|
|
Updated on 13/03/2008 and displayed until 10/02/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 10/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Change of MAH
Change of MA Number
Change of Date of Revision of Text
|
|
Updated on 12/09/2006 and displayed until 13/03/2008
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
| Date of revision of text on the SPC: 04/2004 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
4.5 Interactions: Amended lithium statement
|
|
Updated on 18/05/2004 and displayed until 12/09/2006
|
Reasons for adding or updating:
|
-
Change to section 4.9 - Overdose
|
|
Updated on 14/08/2001 and displayed until 18/05/2004
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 09/07/2001 and displayed until 14/08/2001
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 20/06/2001 and displayed until 09/07/2001
|
Reasons for adding or updating:
|
-
Addition of separate SPCs covering individual presentations
|
|