Summary of Product Characteristics
last updated on the eMC:
26/03/2012
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 26/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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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: 21-Mar-2012 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To remove the pharmacy only status from the licence as this is no longer marketed. As a consequence, sections 4.1 and 6.5 of the SPC and PIL have been updated in addition to minor editorial amendments.
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Updated on 09/11/2011 and displayed until 26/03/2012
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 31-Mar-2011 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Addition of side effects to the SPC to bring it in line with the current ibuprofen core data sheet.
Re date of approval, note that the MHRA did not inform us of approval via the Portal notification. Regulatory followed up on the pending variation to discover that it had been approved on 31.03.11 via the RAMA product history. Approval letters have been requested.
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Updated on 27/10/2010 and displayed until 09/11/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.4 - Special warnings and precautions for Use
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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: 25-Oct-2010 |
| Legal Category: P, GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Correction to list of ingredients and addition of a hypersensitivity warning.
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Updated on 06/05/2010 and displayed until 27/10/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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Company name change or merger
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Change to MA holder contact details
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| Date of revision of text on the SPC: 27-Apr-2010 |
| Legal Category: P, GSL |
| 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 06/05/2010
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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 4.5 - 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 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 10-Feb-2009 |
| Legal Category: P, GSL |
| 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-sode apsirin and ibuprofen-containing products
Corporate labelling
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Updated on 10/01/2008 and displayed until 19/02/2009
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Reasons for adding or updating:
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