Summary of Product Characteristics
last updated on the eMC:
08/02/2011
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 08/02/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
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 4.6 - Pregnancy and Lactation
-
Change to section 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
|
| Date of revision of text on the SPC: 31-Jan-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In Sections 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 & 4.9 the information has been expanded
|
|
Updated on 23/12/2010 and displayed until 08/02/2011
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 01-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Information included regarding a possible interaction with alcohol.
|
|
Updated on 26/02/2009 and displayed until 23/12/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 22-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| In section 7, the name of the MAH has changed from Trinity-Chiesi Pharmaceuticals Ltd to Chiesi Ltd.
|
|
Updated on 14/11/2008 and displayed until 26/02/2009
|
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 |
|