Summary of Product Characteristics
last updated on the eMC:
04/01/2012
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 04/01/2012 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: 01-May-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Under section 6.1 the list of processing aids was missing from the previous update to the SPC. Therefore we are now correcting this in this submission.
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Updated on 11/11/2011 and displayed until 04/01/2012
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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: 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, please 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 31.03.2011 via the RAMA product history. Apporval letters have been requested.
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Updated on 17/05/2011 and displayed until 11/11/2011
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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-May-2011 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The manufacturing site for this product has been transferred from Swindon to Argentina.
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Updated on 25/11/2010 and displayed until 17/05/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 23-Nov-2010 |
| Legal Category: GSL |
| 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.
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Updated on 07/07/2010 and displayed until 25/11/2010
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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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| Date of revision of text on the SPC: 28-Apr-2010 |
| Legal Category: 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 10/05/2010 and displayed until 07/07/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in 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: 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-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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Change to joint SPC covering all presentations
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| Date of revision of text on the SPC: 08-Sep-2008 |
| Legal Category: GSL |
| 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 200mg Capsules" included.
- In section 5.1, data from clinical studies has been added (in the form of a table) to demonstrate that Anadin LiquiFast 200mg Capsules demonstrate pain relieving effects within 30 minutes of dosing.
- In section 5.2, data from PK studies added to demonstrate that Anadin LiquiFast 200mg 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.
- Removal of P (32 capsule) pack size.
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Updated on 26/06/2007 and displayed until 22/12/2008
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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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| Date of revision of text on the SPC: 06/2007 |
| Legal Category: GSL/P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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After renewal MHRA asked to add "The label will include :" in paragragh 4.4
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Updated on 14/03/2007 and displayed until 26/06/2007
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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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| Cardiovascular Warnings added to sections 4.3; 4.4 and 4.8 of the SPC following opinion on non-selective NSAIDs adopted by CHMP October 2006
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Updated on 12/01/2005 and displayed until 14/03/2007
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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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Pending awaiting re-submission
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