Summary of Product Characteristics
last updated on the eMC:
03/02/2012
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 03/02/2012 and displayed until Current
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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 5.1 - Pharmacodynamic Properties
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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: 31-Jan-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4
New Paragraph inserted after Paragraph 4
Interference with laboratory tests
Increased CgA level may interfere with investigations for neuroendocrine tumours. To avoid this interference the omeprazole treatment should be temporarily stopped five days before CgA measurements.
Section 5.1
Other effects related to acid inhibition
Paragraph 3 amended to:
Chromogranin A (CgA) also increases due to decreased gastric acidity. This CgA modifying effect can not be demonstrated five days after stopping treatment with PPIs.
Section 10
Date of revision changed to 31st January 2012.
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Updated on 02/07/2002 and displayed until 03/02/2012
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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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Change to section 9 - Date of Renewal of Authorisation
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Updated on 08/04/2002 and displayed until 02/07/2002
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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 6. 4 - Special Precautions for Storage
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Updated on 24/08/2001 and displayed until 08/04/2002
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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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