Summary of Product Characteristics
last updated on the eMC:
06/10/2010
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 06/10/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 23-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 6.4 of SPC updated
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Updated on 25/08/2009 and displayed until 06/10/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| 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 Holder details
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Updated on 13/02/2009 and displayed until 25/08/2009
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Reasons for adding or updating:
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 14-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 6.6. valve replacement
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Updated on 20/03/2008 and displayed until 13/02/2009
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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: 03/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change to section 4.4 - Special warnings and precautions for use - inclusion of steroid warning
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Updated on 14/01/2008 and displayed until 20/03/2008
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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 01/10/2007 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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change of Market Authorisation Holder address from:
Sherwood House
7 Gregory Boulevard
Nottingham
NG7 6LB
UK
Trading as:
Meda Pharmaceuticals
Regus House
Herald Way
Pegasus Business Park
Castle Doningtom
Derbyshire
DE74 2TZ
UK
to: Meda Pharmaceuticals Ltd.
Building 2000
Beach Drive
Cambridge Research Park
Waterbeach
Cambridge
CB5 9PD
UK
and the PL number has changed from
PL 19477/0010
to
PL 19166/0056
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Updated on 27/09/2006 and displayed until 01/10/2007
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Reasons for adding or updating:
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| Date of revision of text on the SPC: 09/2004 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change name from pramoxine hydrochloride to pramocaine hydrochloride in sections 2, 4.3 and 5.1
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Updated on 12/03/2004 and displayed until 27/09/2006
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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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