Summary of Product Characteristics
last updated on the eMC:
18/11/2009
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 18/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 11-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.3 change of shelf life from 24 months to 18 months.
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Updated on 02/09/2009 and displayed until 18/11/2009
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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: 01-Aug-2009 |
| 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 details
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Updated on 14/01/2008 and displayed until 02/09/2009
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Reasons for adding or updating:
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Change to MA holder contact details
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| Date of revision of text on the SPC: 11/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Address of MA holder changed from
Meda Pharmaceuticals Ltd
Building 2000
Cambridge Research Park
Waterbeach
Cambridge
CB5 9PD
to
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
UK
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Updated on 04/07/2007 and displayed until 14/01/2008
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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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 7 (Marketing Authorisation Holder) has been changed to:
Meda Pharmaceuticals Ltd.
Building 2000
Beach Drive
Cambridge Research Park
Waterbeach
Cambridge
CB5 9PD
UK
Trading as:
Meda Pharmaceuticals
Section 8 (Marketing Authorisation Numbers) have been changed to:
MUSE 125 micrograms PL 19166/0048
MUSE 250 micrograms PL 19166/0049
MUSE 500 micrograms PL 19166/0050
MUSE 1000 micrograms PL 19166/0051
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Updated on 02/09/2004 and displayed until 04/07/2007
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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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Updated on 28/05/2003 and displayed until 02/09/2004
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 22/04/2003 and displayed until 28/05/2003
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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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