Summary of Product Characteristics
last updated on the eMC:
15/10/2008
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 15/10/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 4.4 - Special warnings and precautions for Use
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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 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 19-Aug-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 2 - Qualitative and quantitative composition
Change to section 3 - Pharmaceutical form
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 4.7 - Effects on Ability to Drive and Use Machines
Change to section 4.8 - Undesirable Effects
Change to section 5.1 - Pharmacodynamic Properties
Change to section 6.1 - List of Excipients
Change to section 6.2 - Incompatibilities
Change to section 6. 5 - Nature and Contents of Container
Change to section 6. 6 - Instructions for use, handling and disposal
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Updated on 12/06/2008 and displayed until 15/10/2008
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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