Summary of Product Characteristics
last updated on the eMC:
08/03/2012
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 08/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.3 - Contraindications
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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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| Date of revision of text on the SPC: 31-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1 - "solution" added
Section 2 - "For a full list of excipients, see section 6.1." added
Section 4.3 - hypersensitivity contraindication clarified
Section 4.6 - heading updated to include "fertility"
Section 5.1 - pharmacotherapeutic group added
Section 6.1 - sodium hydroxide and hydrochloric acid added
Section 6.2 - "not applicable"
Section 6.5 - ummarketed pack sizes removed
Section 6.6 - "no special requirements"
Section 9 - dates corrected
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Updated on 17/09/2007 and displayed until 08/03/2012
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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: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
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Updated on 24/08/2005 and displayed until 17/09/2007
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/09/2003 and displayed until 24/08/2005
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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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