Summary of Product Characteristics
last updated on the eMC:
05/10/2011
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 05/10/2011 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: 04-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.2 - information regarding maintenance during unstable angina and acute peripheral arterial occlusion added.
|
|
Updated on 19/03/2010 and displayed until 05/10/2011
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
|
| Date of revision of text on the SPC: 18-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Addition of information relating to "heparin resistance" in sections 4.2 & 4.4.
|
|
Updated on 19/03/2009 and displayed until 19/03/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| 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 |
|
