Updated on 15/06/2011 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 28-Apr-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
4.8 - addition of ‘delerium’ and ‘haematuria’
10 - updated date of revision
|
|
Updated on 13/04/2011 and displayed until 15/06/2011
|
Reasons for adding or updating:
|
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 31-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 6.5 - addition of pack size not marketed in the UK
Section 10 - updated date of revision
|
|
Updated on 19/08/2010 and displayed until 13/04/2011
|
Reasons for adding or updating:
|
-
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
-
Change to section 4.9 - Overdose
-
Change to section 5 - Pharmacological Properties
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.2 - Pharmacokinetic Properties
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 6.1 - List of Excipients
-
Change to section 6.2 - Incompatibilities
-
Change to section 6. 3 - Shelf Life
-
Change to section 6. 4 - Special Precautions for Storage
-
Change to section 6. 5 - Nature and Contents of Container
-
Change to section 6. 6 - Instructions for use, handling and disposal
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 1 -Name of the Medicinal product
-
Change to section 2 - Qualitative and quantitative composition
-
Change to section 3 - Pharmaceutical form
-
Change to section 4.1 - Therapeutic indications
-
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 4.5 - 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
|
| Date of revision of text on the SPC: 13-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| All sections of SPC updated due to harmonisation of SPC
|
|
Updated on 17/10/2008 and displayed until 19/08/2010
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.6 - Pregnancy and Lactation
|
| Date of revision of text on the SPC: 17-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.6 - typo correction
Section 4.8 - Very rare: renal pain.
Renal pain may be associated with renal failure.
|
|
Updated on 02/09/2008 and displayed until 17/10/2008
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 4.9 - Overdose
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 11-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2 - Updated Dosage in Renal impairment
Section 4.4 - Updated Use in patients with Renal Impairment - increased risk of developing neurological side effects
Section 4.8 - Minor update Psychiatric and nervous system disorders
Section 4.9 - Updated symptoms and signs of overdose
Section 10 - Approval date
|
|
Updated on 26/01/2006 and displayed until 02/09/2008
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 20/01/2006 and displayed until 26/01/2006
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 17/01/2006 and displayed until 20/01/2006
|
Reasons for adding or updating:
|
-
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 9 - Date of Renewal of Authorisation
|
|
Updated on 13/12/2005 and displayed until 17/01/2006
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6.1 - List of Excipients
|
|
Updated on 02/12/2004 and displayed until 13/12/2005
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic Indications
-
Change to section 4.2 - Posology and Method of Administration
-
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 27/01/2004 and displayed until 02/12/2004
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
|
|
Updated on 17/12/2003 and displayed until 27/01/2004
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
|
|
Updated on 22/04/2003 and displayed until 17/12/2003
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
|
Updated on 27/03/2003 and displayed until 22/04/2003
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of Renewal of Authorisation
|
|
Updated on 09/01/2003 and displayed until 27/03/2003
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 08/01/2003 and displayed until 09/01/2003
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
|
|
Updated on 19/12/2002 and displayed until 08/01/2003
|
Reasons for adding or updating:
|
-
Change to section 4.6 - Pregnancy and Lactation
|
|
Updated on 25/09/2002 and displayed until 19/12/2002
|
Reasons for adding or updating:
|
-
Improved Electronic Presentation
|
|
Updated on 11/09/2002 and displayed until 25/09/2002
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and Method of Administration
|
|
Updated on 20/08/2001 and displayed until 11/09/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 15/05/2000 and displayed until 20/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 15/05/2000
|
Reasons for adding or updating:
|
|
|
|