Summary of Product Characteristics
last updated on the eMC:
19/08/2011
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 19/08/2011 and displayed until Current
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Reasons for adding or updating:
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.1 - Pharmacodynamic Properties
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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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| Update to SPC sections 4.4 (Special warnings and precautions for use) and 4.5 (Interaction with other medicinal products and other forms of interaction) with further information about photosensitivity. Additionally, minor typographical and formatting changes were made to sections 4.3 (Contraindications) and 5.1 (Pharmacodynamic properties).
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Updated on 17/09/2010 and displayed until 19/08/2011
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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 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 07-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 7 – name of the MAH has changed to Almirall Hermal GmbH
Section 8 – PL number has changed
Section 10 – revision date has changed
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Updated on 26/09/2008 and displayed until 17/09/2010
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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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