Summary of Product Characteristics
last updated on the eMC:
18/05/2009
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 18/05/2009 and displayed until Current
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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: 19-Mar-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In Section 7, MA Holder address changed to:
RAD Neurim Pharmaceuticals EEC Limited
One Forbury Square
The Forbury
Reading
Berkshire RG1 3EB
United Kingdom
e-mail: neurim@neurim.com
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Updated on 24/11/2008 and displayed until 18/05/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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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: 29-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 The ATC code has been revised, and is now as follows:
"Pharmacotherapeutic group: Melatonin Receptor Agonists, ATC code: N05CH01"
Section 5.3 The following text has been inserted:
"The carcinogenicity study in the rat did not reveal any effect which may be relevant for humans."
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Updated on 30/05/2008 and displayed until 24/11/2008
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Reasons for adding or updating:
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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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