Summary of Product Characteristics
last updated on the eMC:
21/10/2009
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 21/10/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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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: 01-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 has been changed from:
Allergic hypersensitivity reactions have occurred rarely following the administration of hydroxocobalamin
And is now as follows:
The following effects have been reported and are listed below by body system:
Disorders of the immune system:
Rare: Allergic hypersensitivity reactions
Very Rare: Anaphylaxis
Gastro intestinal disorders:
Frequency Not Known: Nausea
General disorders:
Frequency Not Known: Fever, dizziness, Injection site disorders
Neurological disorders:
Frequency Not Known: Headache
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Updated on 16/09/2008 and displayed until 21/10/2009
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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: 01-Nov-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change of MA holder to Archimedes Pharma
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Updated on 16/04/2002 and displayed until 16/09/2008
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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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