Summary of Product Characteristics
last updated on the eMC:
21/05/2012
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 21/05/2012 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 11-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.5
Addition of information about about esomeprazole interaction with cilostazol.
Section 5.1
Addition of information about risk of Clostridium difficile infection in hospitalised patients.
Section 10
Date of revision changed to 11th May 2012.
|
|
Updated on 06/10/2011 and displayed until 21/05/2012
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 30-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.4 - Information added re about ‘Interference with laboratory tests’
Section 4.5 - Information added about interaction with St John’s wort, rifampicin and digoxin
Section 5.1 - Information added about the increased levels of Chromogranin A
|
|
Updated on 08/07/2011 and displayed until 06/10/2011
|
Reasons for adding or updating:
|
-
New individual SPC (was previously included in combined SPC)
|
| 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 |
|