Summary of Product Characteristics
last updated on the eMC:
10/03/2011
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 10/03/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Update to section 5.1 Pharmacodynamic properties
|
|
Updated on 25/05/2010 and displayed until 10/03/2011
|
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: 24-Feb-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Licence renewal – change of date
|
|
Updated on 17/03/2009 and displayed until 25/05/2010
|
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: 24-Feb-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Change of Ownership from McNeil Ltd (PL 13249/0029) to McNeil Products Ltd. PL 15513/0348).
|
|
Updated on 17/09/2007 and displayed until 17/03/2009
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|
