Summary of Product Characteristics
last updated on the eMC:
24/07/2006
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 24/07/2006 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 4.4 - Special Warnings and Precautions for Use
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Change to section 6.1 - List of Excipients
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Change to section 4.3 - Contra-indications
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Change to section 5 - Pharmacological Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 03/2005 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 BP has been removed
Section 4.3 The following contra-indications have been added:
Breast-feeding
Porphyria
Allergies to any of the components
Section 4.4 Addition of text to bullet point for liver dysfunction:
· Liver dysfunction – caution should be used in patients with severe hepatic impairments and Deca Durabolin 50mg/ml should only be used if the benefits outweigh the risks.
Additional bullet point:
· diabetes mellitus
Section 5 Addition of heading as shown below:
Section 5.3 Preclinical Safety Data
Not applicable
Section 6.1 EP has been removed from excipients
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Updated on 14/12/2004 and displayed until 24/07/2006
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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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