Summary of Product Characteristics
last updated on the eMC:
06/12/2010
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 06/12/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
|
| Date of revision of text on the SPC: 22-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 - sodium excipient warning added.
|
|
Updated on 09/09/2008 and displayed until 06/12/2010
|
Reasons for adding or updating:
|
-
Change of Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 01-Feb-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
MA Holder amended from 'CP Pharmaceuticals Ltd' to 'Wockhardt UK Ltd'
250mg - PL 04543/0398 amended to PL 29831/0010
500mg - PL 04543/0399 amended to PL 29831/0012
1g - PL 04543/0400 amended to PL 29831/0011
|
|
Updated on 01/10/2002 and displayed until 09/09/2008
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
|