Summary of Product Characteristics
last updated on the eMC:
04/09/2009
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 04/09/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 4.8 (undesirable effects) information on blood dyscrasias has been expanded
|
|
Updated on 19/03/2008 and displayed until 04/09/2009
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Updating section 9 and 10 of the SPC
|
|
Updated on 09/01/2008 and displayed until 19/03/2008
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 08/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update to section 9 and 10
|
|
Updated on 30/09/2005 and displayed until 09/01/2008
|
Reasons for adding or updating:
|
-
Change to section 3 - pharmaceutical form
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MA number
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 26/04/2004 and displayed until 30/09/2005
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 17/09/2001 and displayed until 26/04/2004
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 15/08/2001 and displayed until 17/09/2001
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 01/06/2000 and displayed until 15/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 01/06/2000
|
Reasons for adding or updating:
|
|
|
|