Summary of Product Characteristics
last updated on the eMC:
20/04/2010
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 20/04/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 17-Apr-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Change to Section 6.3 - Shelf Life from
2 Years
to
18 months
|
|
Updated on 15/01/2010 and displayed until 20/04/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 01-Jan-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Change to section 7 - MA Holder:
From:
E Merck Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
To:
Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Change to section 8 - MA Number:
From
PL 00493/0157
To:
PL 11648/0077
Change of Date of Revision of Text to reflect date of approval of variation which updates the SPC:
From:
22 October 2008
To:
01 January 2010
|
|
Updated on 15/10/2009 and displayed until 15/01/2010
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
| Date of revision of text on the SPC: 22-Oct-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
Updated on 22/10/2008 and displayed until 15/10/2009
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 22-Oct-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Changed to section 7 - MA Holder Address:
E. Merck Ltd
Bedfont Cross, Stanwell Road
Feltham, Middlesex,
TW14 8NX, UK
|
|
Updated on 24/09/2007 and displayed until 22/10/2008
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 09/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.6 (Pregnancy and Lactation) has been changed from
'Safety has not been established and animal toxicological studies are lacking, therfore the use of Nutrizym 10 capsules is not recommended'
To
'Safety has not been established and animal toxicological studies are lacking, therfore Nutrizym 10 should not be used in pregnancy and lactation unless clearly necessary, but if required should be used in doses sufficient to provide adequate nutritional status'
Section 10 - (Date of Revision of The Text)
Changed from 16 July 1997 to 20 September 2007
|
|
Updated on 02/07/2001 and displayed until 24/09/2007
|
Reasons for adding or updating:
|
|
|
|
Updated on 02/07/2001 and displayed until 02/07/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 02/07/2001
|
Reasons for adding or updating:
|
|
|
|
