Summary of Product Characteristics
last updated on the eMC:
04/01/2011
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 04/01/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 29-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Minor changes to the wording in sections 2, 3, 4.3 and 5.1 to bring SPC in line with QRD template.
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Updated on 05/10/2010 and displayed until 04/01/2011
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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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| Date of revision of text on the SPC: 16-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Name has changed to "Nalcrom 100mg Capsules" - from NalcromTM
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Updated on 05/01/2009 and displayed until 05/10/2010
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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-Nov-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| C
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Updated on 12/09/2007 and displayed until 05/01/2009
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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: 11/2006 |
| 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 19/09/2006 and displayed until 12/09/2007
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.1 (List of excipients): Addition of excipients to the list
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Updated on 30/09/2005 and displayed until 19/09/2006
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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 - MA number
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Updated on 19/05/2005 and displayed until 30/09/2005
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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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