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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| Section 4.6 (Pregnancy and lactation) and section 10 (Date of revision of the text) has also been changed to the new date 7 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 we have a 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 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 was 24 months now 36 months
section 10 revised date
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Updated on 06/07/2009 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 corrected
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Updated on 20/05/2009 and displayed until 06/07/2009
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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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