Summary of Product Characteristics
last updated on the eMC:
19/06/2009
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 19/06/2009 and displayed until Current
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 23-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 1 - Change of units from "milligrammes/millilitre" to "mg/ml"
Section 2 - Change of units from "milligrammes/millilitre" to "mg/ml" Correction of excipient reference
Section 4.7 - "Not applicable" changed to "Not relevant"
Section 4.8 - MedDRA classification and frequecies applied
Section 6.2 - "None reported" changed to "Not applicable"
Section 6.6 - "No special requirements" added
Section 10 - Date of revision updated
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Updated on 30/03/2009 and displayed until 19/06/2009
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 23-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - Change of units from "milligrammes/millilitre" to "mg/ml"
Section 2 - Change of units from "milligrammes/millilitre" to "mg/ml" Correction of excipient reference
Section 4.7 - "Not applicable" changed to "Not relevant"
Section 4.8 - MedDRA classification and frequecies applied
Section 6.2 - "None reported" changed to "Not applicable"
Section 6.6 - "No special requirements" added
Section 10 - Date of revision updated
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Updated on 21/02/2005 and displayed until 30/03/2009
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 12/02/2004 and displayed until 21/02/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 09/02/2004 and displayed until 12/02/2004
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Reasons for adding or updating:
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Change to section 1 - trade name
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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 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-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 4.8 - Undesirable Effects
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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. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 11/04/2002 and displayed until 09/02/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 10/08/2001 and displayed until 11/04/2002
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 21/11/2000 and displayed until 10/08/2001
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Reasons for adding or updating:
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Updated on 08/11/1999 and displayed until 21/11/2000
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Reasons for adding or updating:
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