Summary of Product Characteristics
last updated on the eMC:
30/07/2007
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 30/07/2007 and displayed until Current
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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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.5 BANs to INNs changes – indometacin, colestyramine
Section 6.1 Change to INNs for excipient – hydroxypropylmethylcellulose to hypromellose
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Updated on 11/07/2006 and displayed until 30/07/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Pending awaiting re-submission
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| Date of revision of text on the SPC: 08/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 - Marketing Authorisation Holder
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Updated on 21/06/2006 and displayed until 11/07/2006
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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: 08/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of MAH from Pharmacia Milton Keynes to Pharmacia Sandwich.
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Updated on 01/09/2004 and displayed until 21/06/2006
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 31/08/2004 and displayed until 01/09/2004
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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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Updated on 26/09/2002 and displayed until 31/08/2004
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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 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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