Summary of Product Characteristics
last updated on the eMC:
26/11/2009
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 26/11/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.3 - Contraindications
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 02-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Following EMEA approval of a Renewal application SPC and PIL were amended ton 2 October 2009 and changes made to sections:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
4.2 Posology and method administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.8 Undesirable effects
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
|
|
Updated on 29/05/2009 and displayed until 26/11/2009
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 22-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Change to section 7. Marketing Authorisation Holder
Change to section 10. Date of the Revision of the Text
|
|
Updated on 01/12/2006 and displayed until 29/05/2009
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.8 - Undesirable Effects
|
| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
section 4.4 of the Summary of Product Characteristics (SPC) to include a statement concerning late onset hepatitis
revision of section 4.8 of the SPC in accordance to the SPC guideline (ADRs presented by MedDRA system organ class and inclusion of frequency categories)
|
|
Updated on 11/01/2006 and displayed until 01/12/2006
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
|
Updated on 23/03/2005 and displayed until 11/01/2006
|
Reasons for adding or updating:
|
|
|
|