Summary of Product Characteristics
last updated on the eMC:
11/11/2009
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 11/11/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
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: 29-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| changes to sections 8. and 10. following approval of change of ownership.
|
|
Updated on 20/10/2008 and displayed until 11/11/2009
|
Reasons for adding or updating:
|
-
Extra statutory information
|
| 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
|
| SPC updated in line with QRD and the latest NSAID guidance.
|
|
Updated on 14/01/2008 and displayed until 20/10/2008
|
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: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| section 7: MA holder changed to
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK
section 8: Product Licence changed to PL 19166/0059
section 10: Changed to Oct 2007
|
|
Updated on 03/07/2002 and displayed until 14/01/2008
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
