Summary of Product Characteristics
last updated on the eMC:
27/04/2012
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 27/04/2012 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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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: 01-Apr-2012 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| section 7 & 8 updated to reflect change in MAH to Forest Laboratories UK Ltd
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Updated on 19/03/2009 and displayed until 27/04/2012
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Reasons for adding or updating:
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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| Date of revision of text on the SPC: 19-May-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to Marketing Authorisation Number Section 9 to PL 00071/0655
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Updated on 09/06/2008 and displayed until 19/03/2009
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Reasons for adding or updating:
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SPC Retired pending re-submission
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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 revision of the text
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| Date of revision of text on the SPC: 19-May-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of a warning regarding Medication Overuse Headache to section 4.4
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Updated on 15/05/2008 and displayed until 09/06/2008
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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 revision of the text
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| Date of revision of text on the SPC: 10-Mar-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 4.8 (undesirable effects), dyspnoea has been added.
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Updated on 22/02/2008 and displayed until 15/05/2008
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.6 - Revision of time frame for witholding breast feeding from 24 to 12 hours
Section 10 -Updated to 15/02/08
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Updated on 21/08/2007 and displayed until 22/02/2008
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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 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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to Section 4.4 and 4.5 Addition of further information regarding serotonin syndrome
Changes to Section 4.8 Removal of tingling from nervous system disorders, and addition of sensory disturbance including paraesthesia and hypoaesthesia. Addition of 'or cold' to general disorders and administration site conditions
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Updated on 08/06/2006 and displayed until 21/08/2007
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Reasons for adding or updating:
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