Updated on 30/03/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 24-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.8 - updated in line with latest CCDS.
Change to section 4.9 - Addition of alopecia and agranulocytosis.
Change to section 10 - 24th March 2011.
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Updated on 12/08/2010 and displayed until 30/03/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 09-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update of SmPC sections 1 (Name of the medicinal product), 2 (Qualitative and
quantitative composition), 3 (Pharmaceutical form), 4.6 (Pregnancy and
lactation), 4.7 (Effects on ability to drive and use machines), 5.1
(Pharmacodynamic properties), 6.1 (List of excipients), 6.3 (Shelf life), 6.4
(Special precautions for storage), 6.5 (Nature and contents of container), 6.6
(Special precautions for disposal) & 8 (Marketing authorisation numbers)
in line with the QRD template.
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Updated on 14/05/2010 and displayed until 12/08/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.8 - Undesirable Effects
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Revised as per latest data; terminology harmonized using MedDRA.
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Change to section 4.9 - Overdose
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Addition of information regarding adverse reactions reported in patients treated at higher dosages for prolonged periods of time.
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Change to section 10 - Date of revision of the text
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11 May 2010
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Updated on 08/05/2009 and displayed until 14/05/2010
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.3 – Shelf Life
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Shelf life reduction to 36 months
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Change to section 10 – Date of revision of the text
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01 May 2009
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Updated on 17/10/2008 and displayed until 08/05/2009
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 01-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 – Marketing Authorisation Holder
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Change of address
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Updated on 01/07/2005 and displayed until 17/10/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 08/11/2004 and displayed until 01/07/2005
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Updated on 15/09/2004 and displayed until 08/11/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 03/06/2004 and displayed until 15/09/2004
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.3 - Preclinical Safety Data
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 27/05/2004 and displayed until 03/06/2004
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.3 - Preclinical Safety Data
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 25/05/2004 and displayed until 27/05/2004
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.2 - Posology and Method of Administration
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Change to section 5.3 - Preclinical Safety Data
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/08/2001 and displayed until 25/05/2004
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 06/09/1999 and displayed until 23/08/2001
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Reasons for adding or updating:
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