Summary of Product Characteristics
last updated on the eMC:
20/10/2011
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 20/10/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change of Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 17-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Laboratoires GENOPHARM
ZI de l’Esplanade
2, rue Niels Bohr
F – 77400 Saint-Thibault-des-Vignes
|
|
Updated on 15/07/2011 and displayed until 20/10/2011
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
-
New individual SPC (was previously included in combined SPC)
-
SPC Submitted in error
|
| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|