Summary of Product Characteristics
last updated on the eMC:
13/04/2011
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 13/04/2011 and displayed until Current
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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: 13-Dec-2010 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises. This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.
In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7. This date is updated to 13th December 2010.
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Updated on 08/02/2007 and displayed until 13/04/2011
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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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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: P |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 4.4 Special warnings and precautions for use - the following has been added
A small number of people may be hypersensitive (allergic) to the constituents of Lipobase.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate may cause allergic skin reactions (possibly delayed).
6.3 Shelf life
The shelf life has reduced from 5 years to 3 years
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Updated on 07/02/2007 and displayed until 08/02/2007
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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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Change to section 6. 3 - Shelf Life
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SPC Retired pending re-submission
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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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4.4 Special warnings and precautions for use - the following has been added
A small number of people may be hypersensitive (allergic) to the constituents of Lipobase.
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Methyl parahydroxybenzoate may cause allergic skin reactions (possibly delayed).
6.3 Shelf life
The shelf life has reduced from 5 years to 3 years
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Updated on 18/01/2006 and displayed until 07/02/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 04/03/2002 and displayed until 18/01/2006
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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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Updated on 10/01/2002 and displayed until 04/03/2002
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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 (partial) revision of the text
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Addition of Legal Category
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Updated on 10/08/2001 and displayed until 10/01/2002
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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 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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Updated on 18/07/2000 and displayed until 10/08/2001
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Reasons for adding or updating:
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Updated on 28/01/2000 and displayed until 18/07/2000
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Reasons for adding or updating:
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Updated on 06/09/1999 and displayed until 28/01/2000
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