Summary of Product Characteristics
last updated on the eMC:
06/04/2009
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 06/04/2009 and displayed until Current
|
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 of Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 27-Mar-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Sections 7, 8 & 9 updated to reflect change in ownership from Schwarz Pharma Ltd to UCB Pharma Ltd.
|
|
Updated on 27/09/2006 and displayed until 06/04/2009
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
| Date of revision of text on the SPC: 07/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 (MA Holder) - New address added: SCHWARZ PHARMA Limited, 5 Hercules Way, Leavesden Park, Watford, WD25 7GS, United Kingdom.
Section 10 (Date of revision of text) - New date added: July 2006
|
|
Updated on 22/12/2005 and displayed until 27/09/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 01/11/2005 and displayed until 22/12/2005
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.3 - Contra-indications
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments 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
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 22/06/2005 and displayed until 01/11/2005
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 15/06/2005 and displayed until 22/06/2005
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 02/06/2005 and displayed until 15/06/2005
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.3 - Contra-indications
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
|
|
Updated on 09/01/2003 and displayed until 02/06/2005
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 26/09/2002 and displayed until 09/01/2003
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 02/08/2002 and displayed until 26/09/2002
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 31/07/2002 and displayed until 02/08/2002
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
-
Change to section 4.3 - Contra-indications
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.9 - Overdose
-
Change to section 6.1 - List of Excipients
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 03/08/2001 and displayed until 31/07/2002
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
-
Change to separate SPCs covering individual presentations
|
|
