Summary of Product Characteristics
last updated on the eMC:
01/06/2011
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 01/06/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 26-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Sections 4.3 (contraindications) and section 4.5 (interactions) have been updated
|
|
Updated on 31/08/2010 and displayed until 01/06/2011
|
Reasons for adding or updating:
|
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
|
| Date of revision of text on the SPC: 13-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.7 has been updated to include the symptoms of dizziness and drowsiness
|
|
Updated on 04/12/2009 and displayed until 31/08/2010
|
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 |
|
