Summary of Product Characteristics
last updated on the eMC:
13/10/2011
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 13/10/2011 and displayed until Current
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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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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Oct-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| To add Catalent Pharma Solutions, Buenos Aires, Argentina as a site responsible for the manufacture of the bulk capsules. In addition there are minor changes to the manufacturing process of the finished product at this site due to slight differences in the equipment used and the different use of processing aids.
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Updated on 09/06/2011 and displayed until 13/10/2011
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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 9 - Date of first Authorisation/renewal of the Authorisation
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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-Jun-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| SmPC updated with additional side effects.
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Updated on 02/02/2011 and displayed until 09/06/2011
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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 6. 4 - Special Precautions for Storage
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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: 27-Jan-2011 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The shelf life has been extended from 2 years to 3 years and the storage conditions reduced to 25degrees.
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Updated on 10/05/2010 and displayed until 02/02/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 27-Apr-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to Marketing Authorisation Holder name and address.
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Updated on 19/02/2009 and displayed until 10/05/2010
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Reasons for adding or updating:
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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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 10-Feb-2009 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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MHRA wording on Minimum Clinical Particulars for ibuprofen
MHRA wording on concomitant use of low-dose apsirin and ibuprofen-containing products
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Updated on 22/12/2008 and displayed until 19/02/2009
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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 5 - Pharmacological 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: 08-Sep-2008 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 1, additional product name "Anadin LiquiFast 400mg Capsules" included.
- In section 5.1, data from clinical studies has been added (in the form of a table) to demonstrate that Anadin LiquiFast 400mg Capsules demonstrate pain relieving effects within 30 minutes of dosing.
- In section 5.2, data from PK studies added to demonstrate that Anadin LiquiFast 400mg Capsules reach peak plasma concentration within 35 minutes of dosing.
- In section 10, date of revision of text has been updated to reflect the latest approval date.
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Updated on 05/09/2007 and displayed until 22/12/2008
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Addition of a statement on the clinical evidence that Ibuprofen 400mg can last up to 8 hours
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Updated on 13/03/2007 and displayed until 05/09/2007
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Reasons for adding or updating:
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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 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update of cardiovascular safety warnings for NSAIDs
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Updated on 21/12/2006 and displayed until 13/03/2007
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Detailed description of the packaging to reflect MHRA SPC version
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Updated on 11/09/2006 and displayed until 21/12/2006
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 24/07/2006 and displayed until 11/09/2006
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Reasons for adding or updating:
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New SPC for new product
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Pending awaiting re-submission
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