Summary of Product Characteristics
last updated on the eMC:
03/05/2011
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 03/05/2011 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 6.1 - List of Excipients
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 21-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8
To include hyponatraemia in metabolism and nutrition disorders in the tables for Hypertension and Post-myocardial infarction and/or heart failure.
Section 6.1
Include type A after crospovidone.
Section 9
Renewal granted on 03 November 2010
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Updated on 02/08/2010 and displayed until 03/05/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 25-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| To update section 1 of the SPC to include Valsartan 80mg Capsules in the name.
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Updated on 22/06/2010 and displayed until 02/08/2010
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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