Summary of Product Characteristics
last updated on the eMC:
10/06/2011
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 10/06/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 26-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| We had to amend these sections to bring them in line with the Core Safety Profile that had been produced by the PSUR work sharing procedure in the EU.
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Updated on 13/07/2010 and displayed until 10/06/2011
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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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| Date of revision of text on the SPC: 07-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| For the SPC the update affects section 4.6 (Pregnancy and lactation) and section 10 (Date of revision of the text) has also been changed to the new date (7th July 2010).
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Updated on 24/09/2009 and displayed until 13/07/2010
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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: 09-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| We have moved premises so this shows our new address
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Updated on 11/08/2009 and displayed until 24/09/2009
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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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: 05-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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section 6.3 has been extended from 24 months to 36 months
section 8 we have a different Marketing Authorisation Number
section 10 revised date
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Updated on 03/07/2009 and displayed until 11/08/2009
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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: 25-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| PL number was corrected
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Updated on 20/05/2009 and displayed until 03/07/2009
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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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