Summary of Product Characteristics
last updated on the eMC:
26/09/2011
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 26/09/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
Change to section 4.3 - Contraindications
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
-
Correction of spelling/typing errors
|
| Date of revision of text on the SPC: 01-Aug-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Changes to sections 1, 4.3, 6.3, 6.5, 7, 9 and 10
Correction of minor typographical/spelling errors
|
|
Updated on 03/08/2010 and displayed until 26/09/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 6.3 (Shelf-Life) has been updated
Section 10 (Date of Revision of the Text) has been updated
|
|
Updated on 23/09/2009 and displayed until 03/08/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 28-Feb-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 7 Marketing Authorisation Holder
The name and address of the MAH have changed from Schwarz Pharma Limited, Watford to UCB Pharma Limited, Slough.
Section 8 Marketing Authorisation Number
The PL number has changed from 04438/0032 to 00039/0737.
Section 9 Date of First Authorisation/Renewal of the Authorisation
The date has changed from September 2003 to 28 February 2008.
Section 10 Date of Revision of the Text
The date 04 July 2007 has been removed from this section.
|
|
Updated on 15/08/2007 and displayed until 23/09/2009
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 6.4: Addition of Store in the original package in order to protect from light
|
|
Updated on 30/06/2006 and displayed until 15/08/2007
|
Reasons for adding or updating:
|
|
|
|