Summary of Product Characteristics
last updated on the eMC:
14/05/2012
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 14/05/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 5.3 - Preclinical Safety Data
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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: 01-May-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.6 Fertility, Pregnancy and Lactation
This section’s header text has had the word Fertility added.
Three sub-headings have been added to this section (Pregnancy, Lactation and Fertility).
The text … (please refer to section 5.3) has been added to the end of the first paragraph under the Pregnancy sub-heading.
New corresponding text has been added to the Fertility sub-heading of this section.
Section 5.3 Preclinical Safety Data
As a result of the new text addition to the Pregnancy sub-heading in section 4.6, completely new text has been added to this section, with deletion of the previous text.
Section 10 Date of Revision of the Text
The date has been amended to May 2012.
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Updated on 21/02/2012 and displayed until 14/05/2012
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Reasons for adding or updating:
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Change to section 5.2 - Pharmacokinetic Properties
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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: 01-Sep-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 5.2 Pharmacokinetic Properties
This section has been re-written with new text and new sub-headings and corresponding text regarding Distribution, Metabolism, Elimination, Elderly subjects, Hepatic impairment and Renal impairment.
Section 10 Date of Revision of the Text
The date has been amended to September 2011.
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Updated on 15/08/2007 and displayed until 21/02/2012
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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 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 5.3 - Preclinical Safety Data
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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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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to headings.
5.3 Preclinical safety data: none
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Updated on 26/07/2004 and displayed until 15/08/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 10 (date of (partial) revision of the text
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Updated on 14/01/2003 and displayed until 26/07/2004
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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 10 (date of (partial) revision of the text
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Updated on 09/08/2001 and displayed until 14/01/2003
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Transferred from eMC version 1
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Updated on 24/07/2001 and displayed until 09/08/2001
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Transferred from eMC version 1
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Updated on 22/03/2001 and displayed until 24/07/2001
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Updated on 13/06/2000 and displayed until 22/03/2001
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