Summary of Product Characteristics
last updated on the eMC:
04/04/2011
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 04/04/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 28-Jan-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Everything is the same but it is a New Licence Number
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Updated on 02/08/2010 and displayed until 04/04/2011
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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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 04-Apr-2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 - Therapeutic Indication: Rewording
Section 4.3 - Contraindications: Rewording
Section 4.4 - Special warnings and precautions for use: new additional warning
Section 4.6 - Pregnancy and Lactation: Precaution added.
Section 9 - Date of first authorisation/Renewal of authorisation: Authorisation renewed |
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Updated on 20/06/2005 and displayed until 02/08/2010
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Reasons for adding or updating:
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