Summary of Product Characteristics
last updated on the eMC:
17/04/2012
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 17/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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| Date of revision of text on the SPC: 01-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Please find attached the revised and updated Gliadel SmPC following approval of the 4 year shelf-life.
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Updated on 03/11/2010 and displayed until 17/04/2012
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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 3 - Pharmaceutical form
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Change to section 4.8 - Undesirable Effects
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Change to section 6.2 - Incompatibilities
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Change to section 6. 6 - Instructions for use, handling and disposal
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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-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Changes to various sections.
Words that have been added are in bold
Section 2:
Removal of the 2nd paragraph describing an excipient "excipient: 192.30mg of polifeprosan 20 per implant".
Section 3:
Off-white to pale yellow flat discoid implant
Section 4.8:
very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100) adverse reactions reported in patients receiving gliadel implant during the clinical trials are listed below.
inserted between the first paragraph and the line: "within each frequency grouping, undesirable effects are presented in order of decreasing seriousness."
Section 6.3:
Not applicable
Replaces: "None known."
Section 6.6:
Any unused product or waste material should be disposed of in accordance with local requirements.
Section 10:
Date of revision of the text change.
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Updated on 23/06/2008 and displayed until 03/11/2010
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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 MA holder contact details
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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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Section 2:addition of "Excipient: 192.30 mg of polifeprosan 20 per implant"
Section 7: The address for MGI has been changed to "Holborn Gate, 1st Floor, 330 High Holborn, London, WC1V 7QT".
Section 7: Removal of the reference to Link as the distributer for Gliadel
The SmPC has been reworded in other sections, however the factual content has remained the same other than those specifically mentioned above.
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Updated on 26/09/2006 and displayed until 23/06/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 03/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Name of MA Holder changed from Guildford Pharmaceuticals Limited to MGI Pharma Limited
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Updated on 04/08/2005 and displayed until 26/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 28/04/2005 and displayed until 04/08/2005
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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Updated on 17/02/2004 and displayed until 28/04/2005
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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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