Summary of Product Characteristics
last updated on the eMC:
16/08/2011
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 16/08/2011 and displayed until Current
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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 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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Change to MA holder contact details
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| Date of revision of text on the SPC: 11-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 - correction of typing error from Refuldan to Refludan.
Section 7 - MA Holders address updated
Section 10 - Date of revision updated to 11 August 2011
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Updated on 04/09/2007 and displayed until 16/08/2011
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Reasons for adding or updating:
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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: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 (undesirable effects) - Brought in line with MedDRA
Section 9 - Change to Date of Renewal
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Updated on 15/02/2007 and displayed until 04/09/2007
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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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