Summary of Product Characteristics
last updated on the eMC:
16/03/2011
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 16/03/2011 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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| Date of revision of text on the SPC: 01-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 7 of the SmPC updated to reflect change of name of MAH from "Laboratorios Almirall SA" to Almirall SA.
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Updated on 07/07/2010 and displayed until 16/03/2011
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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 2 - Qualitative and quantitative composition
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 01-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes made to sections 1, 2, 4.5 and 4.8 reslting from the closure of the renewal procedure.
1. '750mg Capsules' added to name of the product
2. Sentence added referring reader to section 6.1 for a full list of excipients
4.5. Warning added regarding concomittent use of mesalazine and azothioprine or 6-mercaptopurine
4.8 Immune system disorders - Hypersensitivity added.
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Updated on 26/09/2008 and displayed until 07/07/2010
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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: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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