Summary of Product Characteristics
last updated on the eMC:
21/02/2011
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 21/02/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 7 - Marketing Authorisation Holder
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Change to MA holder contact details
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| Date of revision of text on the SPC: 01-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section
2. Qualitative and quantitative composition - addition of below;
1 ml reconstituted suspension contains sorbitol
1 ml reconstituted suspension contains glucose
7. Marketing Authorisation Holder (contact details - address change)
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
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Updated on 22/04/2009 and displayed until 21/02/2011
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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