Summary of Product Characteristics
last updated on the eMC:
18/02/2011
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 18/02/2011 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: 19-Jan-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
As a result of the legal entity approval from Schering-Plough to MSD the following SmPC sections have been updated accordingly:
Section 7, 8 and 10
|
|
Updated on 24/05/2010 and displayed until 18/02/2011
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 13-May-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 2 : Minor amendment to update in line with the current EU QRD template to include "For a full list of excipients, see section 6.1".
Section 6.5 :
Revised to include the newly approved polypropylene screw cap.
|
|
Updated on 02/06/2008 and displayed until 24/05/2010
|
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-Jul-2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Sections 9 & 10 updated following renewal of product licence
|
|
Updated on 24/01/2002 and displayed until 02/06/2008
|
Reasons for adding or updating:
|
-
Change to section 2 - qualitative and quantitative composition
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 9 - Date of Renewal of Authorisation
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 20/08/2001 and displayed until 24/01/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 26/07/2001 and displayed until 20/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 26/07/2001
|
Reasons for adding or updating:
|
|
|
|