Summary of Product Characteristics
last updated on the eMC:
02/06/2008
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 02/06/2008 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 10 date of revision of the text
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Updates to Sections 7, 8, 9 and 10 following approval of the Change of Ownership from Schering Health Care Limited to Bayer plc.
|
|
Updated on 17/12/2003 and displayed until 02/06/2008
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contra-indications
-
Change to section 9 - Date of Renewal of Authorisation
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 21/08/2001 and displayed until 17/12/2003
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 21/08/2001 and displayed until 21/08/2001
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 06/09/1999 and displayed until 21/08/2001
|
Reasons for adding or updating:
|
|
|
|
