Summary of Product Characteristics
last updated on the eMC:
15/08/2007
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 15/08/2007 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
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 5.3 - Preclinical Safety Data
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Changes to headings.
5.3 Preclinical safety data: None
|
|
Updated on 26/07/2004 and displayed until 15/08/2007
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 14/01/2003 and displayed until 26/07/2004
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 09/08/2001 and displayed until 14/01/2003
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 24/07/2001 and displayed until 09/08/2001
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 22/03/2001 and displayed until 24/07/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 13/06/2000 and displayed until 22/03/2001
|
Reasons for adding or updating:
|
|
|
|