Summary of Product Characteristics
last updated on the eMC:
20/09/2011
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 20/09/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 01-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 7 - change of address -
Orphan Europe SARL
Immeuble "Le Wilson"
70 avenue du General de Gaulle
F-92800 Puteaux
France
In section 9 - text added
Date if latest renewal: 23 June 2007
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Updated on 16/04/2008 and displayed until 20/09/2011
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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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